Kornimate/medical-research-clean huggingface dataset:
zero ischemia laparoscopic radio frequency/microwave ablation assisted enucleation of renal cell carcinoma with t1 stage

Conditions: Kidney Neoplasms

Summary: zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for t1a renal cell carcinoma (rcc) in a randomized clinical trial in single center. the investigators want to explore this technique to t1 rcc patients in randomized clinical trial in multiple centers.


Eligibility criteria:
inclusion criteria: * patients with sporadic, unilateral, newly diagnosed t1 presumed renal cell carcinoma * patients scheduled for laparoscopic nephron sparing surgery * patients agreeable to participate in this long-term follow-up study exclusion criteria: * patients' aged \>80 years * patients with other renal diseases,(including kidney stone, glomerular nephritis, etc.) which might affect the renal function of the operative kidney * patients not able to tolerate the laparoscopic procedure * patients with previous renal surgery or history of any inﬂammatory conditions of the operative kidney * patients with the renal tumor involving urinary collecting system

Keywords: nephron sparing surgery zero ischemia warm ischemia laparoscopic radiofrequency ablation microwave ablation
an open-label multiple dose study of rz358 in patients with congenital hyperinsulinism

Conditions: Congenital Hyperinsulinism

Summary: the objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of rz358 in patients with congenital hyperinsulinism (hi).

there is a significant unmet medical need to develop new therapies aimed at preventing chronic recurrent hypoglycemia in congenital hi, the most common cause of persistent hypoglycemia in children. rz358 is a human mab that allosterically attenuates excessive insulin action on target cells. therefore, rz358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital hi. this is a phase 2, multicenter, open label clinical study designed to assess the safety and efficacy of four progressively higher doses of rz358 in separate groups of patients with hyperinsulinemic hypoglycemia due to congenital hi, not adequately controlled with or without current standard of care. a screening period of up to 5 weeks will evaluate eligibility. once enrolled, rz358 will be administered bi-weekly over 8 weeks, and then patients will complete a post-treatment follow-up period of 13 weeks.

Eligibility criteria:
inclusion criteria: * male or female age 2-45 years old (except age 12-45 in us) with an established clinical diagnosis of congenital hyperinsulinism * able to provide written informed consent or, as applicable, assent * confirmed hypoglycemia as assessed by cgm, smbg, and clinical evaluation, during screening * willingness to use contraception if of child-bearing potential exclusion criteria: * out of range blood work for study entry * body mass index outside of study entry criteria * history of malignancy * clinically significant diseases, seropositivity for hiv, hepatitis b or c antibody * use of systemic corticosteroids within 30 days before screening * known or suspected allergy to the study drug * recent use of an investigational drug or treatment, or participation in an investigational study * pregnant or lactating women * history of drug abuse or excessive alcohol use

Keywords: hypoglycemia congenital hyperinsulinism glucose metabolism disorders metabolic diseases pancreatic diseases digestive system diseases hyperinsulinism
the impact of sensory integration on attention in autism

Conditions: Autism; Autism Spectrum Disorder

Summary: the study aims to examine how the mode of presentation of visual and auditory stimuli-separate or simultaneous-affects accuracy and reaction time in visual-auditory association in participants with autism spectrum condition (asc) compared to neurotypical individuals. the study aims to evaluate whether sensory overlap (simultaneous stimuli) increases cognitive load and decreases performance, while stimulus separation (separate presentation of visual and auditory stimuli) may facilitate processing and improve performance, especially in participants with asc. participants will be divided into two main groups: the first consisting of individuals with asd and the second of neurotypical individuals. each group will be exposed to two modes of stimulus presentation: simultaneous mode, in which visual and auditory stimuli are presented at the same time, and separate mode, in which visual and auditory stimuli are presented separately with a time interval between each. participants will be required to complete visual-auditory association tasks. in addition to assessment of reaction time and accuracy, psychophysiological parameters will be recorded to measure cognitive load and physiological reaction to stimuli. the main hypotheses are that the simultaneous presentation of visual and auditory stimuli will increase cognitive load and reduce accuracy and reaction time in individuals with asc, while the separate mode will improve performance, especially in the group with asc. this study could provide important insights into how stimulus presentation mode affects learning and performance in participants with asc, suggesting that stimulus separation could be a useful strategy for optimizing sensory processing and improving learning in educational and therapeutic settings.


Eligibility criteria:
inclusion criteria: * diagnosis of autism * qi ≥ 80 exclusion criteria: * significant hearing or visual impairments * presence of other medical disorders * history of psychiatric diagnosis

Keywords: autism autism spectrum condition utism spectrum disorder sensory overload sensory processing sensory integration
effects of the "spinomed active" orthosis on chronic back pain in women with vertebral fractures.

Conditions: Osteopenia; Kyphosis

Summary: osteoporotic vertebral fractures often lead to postural changes, chronic spinal pain conditions and limited functionality. orthoses that straighten the spine have been shown in studies to have a positive effect on pain, posture and the functional state of patients with a fresh vertebral fracture. the planned study investigates the effect of the orthosis "spinomed active" in patients aged ≥ 65 years with at least one non-acute osteoporotic vertebral fracture (at least 3 months ago) and chronic back pain.


Eligibility criteria:
inclusion criteria: * living independently in the community * ≥ 1 low-traumatic vertebral fracture ≥ 3 months ago * chronic back pain according to the national guideline for low back pain * mean back pain intensity nps ≥ 1 (1-10 scale) * hyperkyphosis, kyphosis angle according to debrunner \>40° * intact skin or adequate wound coverage in the area of the contact surface of the orthosis exclusion criteria: * secondary osteoporosis (as determined by study physician) * expected change in overall pain therapy during the study period * structurally fixed kyphosis, lack of extension ability of the thoracic spine * kyphoplasty, vertebroplasty * use of back orthoses during the last 6 months * depression * dementia, cognitive impairment (mini mental test \< 25) * fresh neurological deficits; incontinence \> grade 1 * body dimensions that do not allow for adjustment of the back orthosis * absence during baseline and follow-up assessments
precise diagnosis, treatment and prognostic evaluation of complicated adrenal tumor diseases

Conditions: Complicated Adrenal Tumor Diseases

Summary: the adrenal gland is an important organ that produces life hormones. there are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. it has the dual threat: hormone secretion and tumor metastasis. at present, there are four major dilemmas in the clinical diagnosis and treatment of adrenal tumors: 1) pulse secretion of the hormones, which are affected by many factors; and the diagnostic value of single hormone is limited; 2) traditional imaging cannot accurately reflect the characteristics of hormone secretion. the prognosis cannot be accurately predicted; 3) the molecular characteristics of tumor cells and the microenvironment are unclear, making it difficult to implement early diagnosis and precise treatment; 4) traditional pathology cannot determine the nature and long-term prognosis of the tumor, which makes the treatment delay, and the disease prognosis is extremely poor. it threatens the lives of patients. starting from solving the above-mentioned key problems in the early stage, the research team has systematically established new clinical diagnostic technologies, hormone dynamic tests to accurately assess hormone secretion and segmented blood collection hormone determination technologies to accurately locate adrenal tumors; a series of important research results have been published in science, lancet diabetes \& endocrinology, cell research, etc to sum up, the goal of this research is improving the early diagnosis rate of complicated adrenal tumors especially in malignant tumors, developing the optimal treatment plan, avoiding unnecessary surgical treatment, improving the quality of life of patients, reducing mortality. this project will further integrate the adrenal cortex and medulla hormone mass spectrometry detection and the molecular markers of adrenal tumors through phenotypic, functional imaging, and molecular pathological evaluations, and built a sensitive drug screening platform that integrates visual drug response and molecular characteristics, thereby achieving precise diagnosis and treatment of complicated adrenal tumors.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old and ≤ 75 years * diagnosis of patients with primary aldosteronism, pheochromocytoma, and cortical cancer * gender: males and females * provide written informed consent * satisfactory compliance exclusion criteria: 1. patients with renal insufficiency (cr\>2 times the upper limit of normal). 2. patients with a history of liver cirrhosis. 3. patients who are currently using corticosteroids. 4. patients with cardiac insufficiency (nyha cardiac function classification grade 3 and above or ef\<50%). 5. patients with stroke and acute myocardial infarction in the past 6 months. 6. patients during pregnancy and lactation
patients decision making in choosing between colonic investigation alternatives

Conditions: Colonic Disease

Summary: this is a qualitative interview study to understand patients' priorities for different aspects of tests when considering a colonic investigation. patients currently waiting for colon capsule endoscopy (cce), and colonoscopy will be invited to take part. semi-structured interviews will be carried out over the telephone following an interview guide. recorded interviews will be transcribed and undergo thematic analysis. we will seek to publish the results of this study to inform future research and developments for colonic investigations.


Eligibility criteria:
inclusion criteria: * patients over 18 who are on the waiting list for a colonoscopy or cce. only patients who can provide valid consent will be included. * english language speaking (translation services are not available for this study). exclusion criteria: * patients undergoing colonoscopy due to positive bowel screening test or due to surveillance of known colonic pathology.
real-world registry study on clinical analgesic effect of acetylaconitine tablets

Conditions: Chronic Pain

Summary: 1. to observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine. 2. to study and analyze the main influencing factors of the acetylaconitine tablets.

the outpatients/inpatients meeting the criteria are included into this study after signing the informed consent form. the patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and app follow-up.

Eligibility criteria:
inclusion criteria: * patients with chronic pain \> 1 month and vas \> 40 mm patients who can take the acetylaconitine tablets orally exclusion criteria: * patients who cannot communicate or receive follow-up patients allergic to acetylaconitine patients who have taken the acetylaconitine drugs orally
the use of plco-vacuum-system on sternal wounds

Conditions: Cardiac Surgery; Wound Infection; Wound Healing Disorder

Summary: the use of a vacuum-assisted wound closure system (pico, fa. smith \& nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.

median sternotomy remains the standard surgical approach for most cardiac surgeries. however, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. this risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. in such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%. several strategies aim to reduce the risk of sternal wound infections. one approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like prevena (fa. kci). the pico-system operates with a distinct vacuum pressure mechanism and a unique film design compared to the prevena system. to date, no prospective randomized studies have evaluated the pico-system for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. this study aims to compare conventional plaster wound care with the pico vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.

Eligibility criteria:
inclusion criteria: all patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors: * diabetes mellitus (treated with oral antidiabetics and/or insulin) * lvef\&lt;40% * copd * female gender * adipositas (bmi \&gt; 30kg/m2) * history of myocardial infarction (nstemi or stemi) within 14 days * known peripheral arterial disease * planned bima surgery. exclusion criteria: * planned hemisternotomy or anterolateral thoracotomy * emergency cases * lack of consent * active therapy with immunosuppressants (including steroids)

Keywords: vacuum wound dressing pico sternal wound healing disorder
cross-disciplinary hiv integrated mental health support intervention

Conditions: Human Immunodeficiency Virus; HIV Infections

Summary: the proposed project seeks to develop and test an intervention to improve engagement in hiv and mental health care for young black gay, bisexual and other men who have sex with men (yb-gbmsm) in ryan white clinics.

young black gay, bisexual and other men who have sex with men (yb-gbmsm) are disproportionately impacted by hiv, with suboptimal rates of engagement across the hiv continuum of care (hiv-coc). mental health (mh) comorbidities contribute to poor hiv care engagement for many yb-gbmsm; however, effective treatment for these conditions is hindered by barriers including logistical challenges, medical mistrust, and mh stigma. the ryan white care act supports integration of hiv and mh services; however, preliminary studies demonstrate low rates of mh referrals and mh care engagement among yb-gbmsm living with hiv, even in these ostensibly integrated care settings. the objective of this study is to develop and implement chimes (cross-disciplinary hiv integrated with mental health support), a clinic- and provider-level intervention to improve hiv-mh care integration and mh care engagement among yb-gbmsm attending ryan white clinics. the rationale for this study is that efforts to improve integration of services, particularly if they are culturally tailored, are likely to increase mh and hiv care engagement for yb-gbmsm. the proposed study will pursue two specific aims: (1) to develop the chimes intervention; and (2) to conduct a hybrid type 2 implementation-effectiveness pilot trial of chimes in two health resources and services administration (hrsa)/ryan white-funded clinics in atlanta, georgia - a city in the heart of the southern hiv epidemic. for the first aim, the researchers will work collaboratively with provider and patient stakeholders, adapt existing evidence-based interventions, and build on formative data to refine intervention content, informed by the capability- opportunity-motivation-behavior (com-b) model. for the second aim, the researchers will implement chimes in the two clinic settings and conduct a mixed-methods assessment in which continuous data collection informed by the reach, effectiveness, adoption, implementation, maintenance (re-aim) framework will be used to evaluate effectiveness and implementation processes. the effectiveness of the chimes intervention will be measured by change in hiv and mh care engagement before, during, and after chimes implementation. the researchers will abstract clinic-level aggregate data to characterize change in hiv-coc and mh care engagement outcomes for yb-gbmsm.

Eligibility criteria:
inclusion criteria: * young black gay, bisexual and other men who have sex with men (yb-gbmsm) living with hiv * patient at grady health system infectious disease program or emory university hospital midtown infectious disease clinic exclusion criteria: * none

Keywords: mental health
iph5401 (anti-c5ar) in combination with durvalumab in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of iph5401 (anti c5ar) in combination with durvalumab (medi4736) in adult subjects with selected advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients with advanced and/or metastatic histologically solid tumors with evidence of active disease, who have been treated with a minimum of one line of systemic therapy in the metastatic setting, and in expansion part, no more than two prior systemic therapies. 2. at least 18 years of age. 3. ecog performance status of ≤1. 4. adequate organ function exclusion criteria: 1. for patients with non small cell lung cancer (nsclc): a. known actionable mutation or rearrangement (including but not limited to the epidermal growth factor receptor (egfr), anaplastic lymphoma kinase (alk) gene rearrangements, ros-1 alterations or braf mutations) 2. for patient with hepatocellular carcinoma (hcc): 1. hepatic encephalopathy in the past 12 months. 2. ascites that requires repeated paracentesis in the past 2 months. 3. main portal vein thrombosis. 4. active or prior history of gastrointestinal bleeding in the past 12 months. 5. prior hepatic transplantation. 3. patients with known spinal cord compression. 4. symptomatic, untreated, or actively progressing central nervous system (cns) metastases.
cerebrospinal fluid (csf) raltegravir substudy

Conditions: HIV Infections

Summary: the purpose of this study is to measure concentrations of raltegravir in cerebrospinal fluid. the hypotheses are: * raltegravir concentrations in csf will be measurable * raltegravir concentrations in csf will remain constant, while plasma concentrations vary widely leading to highly variable csf-to-plasma ratios. * following at least 4 weeks of raltegravir-containing combination therapy, hiv rna levels in csf will be below 50 copies/ml in all subjects.


Eligibility criteria:
inclusion criteria: * enrollment in a raltegravir parent protocol at ucsd. * willing to undergo lumbar puncture. * able to give informed consent. if cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure. exclusion criteria: * relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets\<50,000/µl), hemophilia, or use of anticoagulant medication. * psychiatric disease that would interfere with study participation, in the opinion of the investigator. * no major opportunistic infections within 30 days. * moderate or severe cognitive impairment. the proposed study does not have a neuropsychological objective.

Keywords: human immunodeficiency virus cerebrospinal fluid raltegravir drug concentrations
management of infection risk in non-comparative trial (mint)

Conditions: Venous Leg Ulcer

Summary: the urgo2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of tlc-ag healing matrix and fibres. the dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection. the purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the urgo2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

the urgo2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

Eligibility criteria:
inclusion criteria: * adult patient, aged ≥ 18 years, who signed and dated informed consent form, * patients affected by vlu or mixed ulcer of predominantly venous origin (ankle brachial pressure index (abpi) ≥ 0.7 and ≤ 1.3), * patient willing and able to wear an effective venous compression system every day during the study period, * patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate. exclusion criteria: * patients under guardianship or protection of vulnerable adult * pregnancy or breastfeeding women, * childbearing potential women with no medically-acceptable method of birth control, * patients included in another clinical study, * patients with known allergy with hydrocolloid (carboxymethylcellulose cmc), silicone or silver, * patients with wound covered partially or totally with necrotic tissue, * patients who had within the 3 months prior the inclusion, deep vein thrombosis * patients with a serious general disease that deemed to interfere with the treatment period and evaluation * patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy * patients with non-controlled systemic infection by an suitable antibiotic therapy * patients with clinically infected wound * patients with wound requiring surgical treatment or for which surgery is scheduled during the study period * patients with known cancerous lesions