Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of nivolumab with ipilimumab in participants with untreated advanced kidney cancer conducted in india

Conditions: Kidney Neoplasms

Summary: the purpose of this study is to assess the safety and efficacy of nivolumab combined with ipilimumab in intermediate and poor-risk participants with previously untreated advanced renal cell carcinoma (rcc) or metastatic rcc (mrcc) in india.


Eligibility criteria:
inclusion criteria: * histological confirmation of renal cell carcinoma (rcc) with clear cell component including participants who may have sarcomatoid features * qualifies as intermediate or poor risk by meeting at least one of the prognostic factors as per the international metastatic rcc database consortium (imdc) criteria * indian participants with indian ethnicity living in india * no prior systemic therapy for rcc * measurable disease lesion by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors (recist) 1.1 criteria exclusion criteria: * participants with active, untreated, symptomatic central nervous system (cns) metastases * major surgery less than 28 days prior to the first dose of study treatment * participants with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids or other immunosuppressive medications other protocol-defined inclusion/exclusion criteria apply
protein-bound toxin removal between limited blood flow super high-flux online hdf and high-efficiency online hdf

Conditions: End-stage Renal Disease; Hemodialysis

Summary: high-efficiency post-dilution online hemodiafiltration (ol-hdf) using high-flux dialyzer and requiring high blood flow rate (bf ≥400 ml/min) has been reported to enhance protein-bound toxin and middle molecular toxin removal and improve patient survival. unfortunately, the majority of patients could not reach that high bf because of vascular access issue. this randomized crossover study was conducted to compare these uremic toxin removals between the new modality (limited bf ol-hdf with super high-flux dialyzer) and the control (high-efficiency ol-hdf). the ol-hdf patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.

elevated protein-bound toxins including p-cresol (pcs) and indoxyl sulfate (ids) as well as middle-molecular toxins such as beta2-microglobulin (b2m) which could not be removed by hemodialysis (hd) are obviously correlated with high mortality. high-efficiency post-dilution online hemodiafiltration (ol-hdf) using high-flux dialyzer and requiring high blood flow rate (bf ≥400 ml/min) has been reported to enhance pcs, ids, and b2m removal and improve patient survival. unfortunately, the majority of patients could not reach that high bf because of vascular access issue. we innovated the ol-hdf modality for this limited bf situation by integrating the novel super high-flux membrane dialyzer (shf; pes-17dα, nipro corporation, japan) into pre-dilution ol-hdf. this randomized crossover study was conducted to compare the uremic toxin removals between the new modality (limited bf ol-hdf with shf) and the control (high-efficiency ol-hdf). the ol-hdf patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks. removals of pcs and ids as well as small and middle molecule toxins were compared. the pcs and ids were measured by high performance liquid chromatography. the dialysate albumin loss and patient safety were also monitored.

Eligibility criteria:
inclusion criteria: * end-stage renal disease patients treated with thrice-a-week ol-hdf for at least 6 months * residual urine \< 100 ml/day exclusion criteria: * active cardiovascular disease * active malignancy * pregnancy * breast-feeding

Keywords: online hemodiafiltration super high-flux dialyzer protein-bound uremic toxin p-cresol
nutrition and obesity in under-represented populations: food insecurity research to advance science and improve health

Conditions: Pediatric Obesity; Food Insecurity; Nutrition, Healthy; Nutrition Poor

Summary: food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. while existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. the purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (bmi) over one year, and if so, by what mechanisms. the investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. both will provide families with $50/week for one year of study enrollment. the first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). the investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. the primary endpoint is difference in bmi at 12 months post-enrollment (24 months of age). secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. data analysis will be conducted by a trained statistician (duke biostatistics, epidemiology, and research design; berd) and will employ a two-means test for a repeated-measures design. the benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.


Eligibility criteria:
inclusion: * aged 9-12 months and their primary caregiver "parent". * medicaid and wic-eligible (proxy for "at risk for food insecurity") * world health organization bmi ≥ 85%ile at current or most recent encounter (early-onset obesity) or ≥ 20 pounds at 9 months old. * caregiver speaks either english or spanish as their primary language. * infant was born as a singleton infant. exclusion: * diagnosed with monogenic obesity. * plans to move from the area in the next 12 months. * parent is currently pregnant.
post market surveillance to observe safety of prevenar13™ in adults

Conditions: Pneumococcal Disease

Summary: the purpose of this study is to assess safety profile of prevenar 13™ when used among korean adults in the routine clinical setting, as required for any new drug approved by korea food and drug administration (kfda).

non-randomization, non-probability sampling

Eligibility criteria:
inclusion criteria: korean adults aged 18 years and older; provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the local product document do not apply. * evidence of a personally signed and dated informed consent document indicating that the subject(or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: subjects who are not indicated and/or contraindicated for the prevenar13 usage will not be included.
efficacy and safety study of cc-4047 (pomalidomide) to treat advanced soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of the study is to determine the safety and efficacy of single agent cc-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.


Eligibility criteria:
inclusion criteria: * must be \> 18 years of age * must have histologically confirmed soft tissue sarcoma * must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens * must have measurable or evaluable disease determined as per response evaluation criteria in solid tumors (recist) criteria * must have documented disease progression (pd) determined as per recist criteria within 3 months prior to study enrollment * must have eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * pregnant or lactating females * prior therapy with thalidomide or lenalidomide * prior use of experimental/investigational drug therapy \< 3 months prior to treatment initiation * prior chemotherapy, biologic or immunotherapy \< 3 weeks prior to treatment initiation * prior radiotherapy \< 3 weeks prior to treatment initiation * prior major surgery \< 3 weeks prior to treatment initiation * absolute neutrophil count (anc) \< 1.5 x 109 cells/l * platelet count \< 100 x 109cells/l * aspartate aminotransferase/serum glutamic oxaloacetic transaminase (ast/sgot) and alanine aminotransferase/serum glutamic pyruvate transaminase (alt/sgpt) \> 3.0 x upper limit of normal (uln) or \> 5.0 x uln in the presence of demonstrable liver metastases * known active central nervous system (cns) metastases

Keywords: soft tissue sarcoma cc-4047 pomalidomide
retrieval of patient information after discontinuation

Conditions: Alzheimer's Disease

Summary: a phase 3b, study of subjects with alzheimer's disease who discontinued treatment in bapineuzumab phase 3 clinical studies (eln115727-301/302/351) or who completed studies eln115727-301 and 302 but did not enroll in study eln115727-351.


Eligibility criteria:
1. signed, dated, and written informed consent obtained from the subject and/or the subject's legally acceptable representative (lar, if applicable) in accordance with local regulations. 2. signed, dated, and written informed consent, obtained from the subject's caregiver in accordance with local regulations. 3. subject must have participated in the study 301, 302, or 351 and have received at least 1 dose of study treatment (bapineuzumab or placebo). 4. subject must have been off treatment for at least 12 months prior to visit 1. 5. subjects must have a primary caregiver for the duration of the study. 6. subject's caregiver must have the ability to assess the subject and answer questions over the phone.
investigation of the effect of body mass index and anxiety on masseter muscle thickness on ultrasonography

Conditions: Anxiety

Summary: the aim of this study is to determine the effect of body mass index (bmi) and anxiety on masseter muscle thickness by using ultrasonography.

the aim of this study is to determine the effect of body mass index (bmi) and anxiety on masseter muscle thickness by using ultrasonography. a total of 68 patients were included in this study. height and weight of the patients were measured. bmi was calculated. the control group without anxiety - normal bmi (15 patients) was composed of patients in general. working groups were formed as high bmi \& anxiety normal (19 patients), normal bmi \& high anxiety (15 patients), and high bmi \& high anxiety (19 patients). the hospital anxiety depression scale (hads) was applied to the participants. muscle thickness measurements were first measured by using the high-frequency linear scanning probe of an ultrasound device to measure the contraction and relaxation of the right masseter muscle. then, the contraction and relaxation of the left masseter muscle was measured.

Eligibility criteria:
inclusion criteria: * the study group consisted of individuals between the ages of 18 and 45 who, according to an examination of the masseter muscles under the 'research diagnostic criteria for temporomandibular disorders (rdc/tmd),' had the presence of pain in at least one region in the palpation made from three regions (origin, center, attachment zone) or had pain in chewing muscles in the preceding month. exclusion criteria: * exluded from the study where those who had experienced any systemic discomfort from the study group, those who had undergone acute temporomandibular joint trauma, those who had experienced early occlusion of the teeth, those who were using any moving dental prosthesis, those with clenching habits, those who use cigarette-alcohol, those with temporomandibular joint discomfort, and those with unilateral chewing habits.

Keywords: anxiety body mass index masseter muscle obesity ultrasonography
examination of the relationshıp between body mass index and the skin-epidural space distance

Conditions: Anesthesia Awareness

Summary: aim: the aim of the study; to investigate whether there is a relationship between body mass index (bmi), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by usg.

the research was carried out in the block room in the preoperating room of dokuz eylül university practice and research hospital and with 42 volunteer operating room workers aged between 18-59 years. height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (usg) separately by an anesthesiologist and a radiologist. for ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower sias levels were examined with convex probe as transverse median. in addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. the statistical correlations of all measurements were examined.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 59 years old. 2. asa i-ii classification. 3. body mass index (bmi): 18.5-29.9 kg/m2. exclusion criteria: 1. individuals under 18 or over 59 years old. 2. those with a history of vertebral surgery. 3. patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis \ 80 degrees). 4. individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis. 5. presence of wounds or infections in the lumbar region. 6. volunteers who underwent epidural or spinal interventions in the lumbar region within the last month. 7. individuals with bone implants affecting posture, such as hip or knee prostheses. 8. pregnant women. 9. individuals with conditions like cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema. 10. volunteers using corticosteroids. 11. obese individuals (bmi: \>29.9).
the newly reported (0-90°) versus (0-30°) biplanar fluoroscopic puncture technique in pcnl

Conditions: Nephrolithotomy, Percutaneous; Kidney Stone; PCNL

Summary: to analyze and compare the puncture success rate, puncture fluoroscopy time and intraoperative puncture complications of two different puncture techniques; fluoroscopic bi-planar (0-30º) versus newly reported bi-planar (0-90º) technique in pcnl.

nephrolithiasis is one of the most common urological diseases, it is a widespread and challenging issue for both patients and healthcare systems. it is responsible for a significant financial and psychological burden, with an increased incidence of disease. the eau (european association of urology) guidelines recommend percutaneous nephrolithotomy in patients with kidney stones \>2 cm. the most crucial step of the procedure is the precise puncture of the caliceal system. this can be accomplished by the use of fluoroscopy, ultrasound, or the combination of both and new other imaging modalities techniques. among them, fluoroscopy is the most common method for conducting the percutaneous puncture by urologists worldwide using multiple mono-planar or bi-planar fluoroscopic techniques. however, all fluoroscopic approaches face the same limitation, which is the difficult interpretation of the three-dimensional renal anatomy based on the two-dimensional x-ray information. another disadvantage is the amount of fluoroscopic radiation used. surgeons, assistants, nurses and patients, however, all have to accept various levels of radiation exposure. numerous researches have revealed that it is still harmful to the human body who is exposed to radiation frequently, although under the aegis of protective aprons and thyroid shields, thus the application is affected to varying degrees. fluoroscopic bi-planar techniques provide better information about the depth and direction of the collecting system than mono-planar methods. the most popular bi-planar methods described in the literature are the triangulation (0-30º), the "bull´s eye" technique and the less known bi-planar technique (the 0-90º technique) described by dr. paul escovar. a newly published (0-90º) technique by braulio o manzo et al to increase the accuracy of calculating the needle path to the exact calyx depth and decreases its radiation exposure. in the current study, the investigator aimed to compare two different renal access techniques; fluoroscopic 0-30 and modified 0-90 technique regarding success rate, fluoroscopy time and intraoperative puncture complications.

Eligibility criteria:
inclusion criteria: * a patient over 18 years old. * renal stone 2 cm or greater. exclusion criteria: * a patient \< 18 years old. * congenital anomalies of the kidney: horseshoe kidney, malrotated kidney, pelvic ectopic kidney. * patient with obvious spinal deformity. * coagulopathies.

Keywords: pcnl 0-30º biplanar new 0-90º pcnl puncture techniques 090 pcnl 030 pcnl
a study of relatlimab plus nivolumab versus nivolumab alone in participants with advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * participants must have histologically confirmed stage iii (unresectable) or stage iv melanoma, per the ajcc staging system * participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma * tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses exclusion criteria: * participants must not have active brain metastases or leptomeningeal metastases * participants must not have uveal melanoma * participants must not have an active, known, or suspected autoimmune disease other protocol defined inclusion/exclusion criteria could apply

Keywords: cancer advanced cancer
neuroinflammatory response in patients with ich and ivh treated with rtpa

Conditions: Hypertensive Intracerebral Hemorrhage; Intraventricular Hemorrhage; Brain Injuries

Summary: this study compares the neuroinflammatory response in patients with hypertensive ich associated with ivh treated with intraventriculary applied rtpa, and the control group. the inflammatory mediator concentration is analyzed in local cerebrospinal liquor.


Eligibility criteria:
inclusion criteria: * subjects with primary ich with ivh * ich score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle * patient is not considered a surgical candidate by neurosurgery service exclusion criteria: * no history of diseases or drugs that affect the immunological system. * ich score 1 and 5 * current participation in another research drug treatment protocol * previously known intracranial arteriovenous malformation or aneurysms * intracerebral hematoma considered to be related to trauma * ich is located in the pons * blood in the subarachnoid space visualized on ct scan

Keywords: secondary brain injury neuroinflammation
acoustic analysis of va sounds

Conditions: End Stage Renal Disease; Hemodialysis Access Failure

Summary: end-stage renal disease (esrd) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. the majority of esrd patients is on hemodialysis (hd) treatment. a successful hd procedure requires a functioning vascular access (va) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. the current recommendation for va is the native arteriovenous fistula (avf), surgically created in the forearm by an anastomosis between a vein and an artery. the avf, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new va. an arteriovenous graft (avg) is the second choice for a va. surgery is done using an artificial plastic tube that connects an artery to a vein. the avg matures earlier than avf (2/3 vs 6 weeks), but it is more prone to infections and has lower survival. it would be important to identify patients at risk of va failure, but there is currently a lack of adequate strategies for surveillance. a continuous monitoring of the va function would help in identification of reduced blood flow and va stenosis, that could be treated by interventional radiologists before avf or avg complete closure. over the years, nurses and nephrologists got used to touch the va and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope. the purpose of this study is to assess the feasibility of va sound recording and analysis and provide preliminary evidence of va sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in avfs and avgs. this is a single center prospective observational study involving the acquisition of va sounds and doppler us examinations in consenting patients with esrd. to reach this goal, two groups of esrd patients in need of va surgery to perform hd treatment will be involved: group 1. patients with avf as first line hd access option. group 2. patients with avg as first line hd access option.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures. 2. patients in hd treatment that need a new va or patients that entered the pre-dialysis program because of esrd. in all these cases the treatment of first choice should be the creation of a distal autogenous avf, the creation of an avg or the proximalization of an occluded va. exclusion criteria: 1. contraindications for the creation of an autogenous avf, for the avg creation or the proximalization of a failed va. 2. patients who use catheter to perform hd. 3. patients undergoing peritoneal dialysis. 4. patients with life expectancy less than 2 years.

Keywords: avf avg va sounds acoustic analysis va remodelling doppler ultrasound