Kornimate/medical-research-clean huggingface dataset:
stereotactic body proton therapy for treatment of primary renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this study examines the impact of proton based stereotactic radiation therapy (sbrt) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.

the incidence of kidney cancer diagnosis has been increasing over the last years. surgical resection represents the mainstay treatment. however, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. there are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (sbrt). sbrt using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (rcc) in terms of local control and toxicity. however, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. with this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. this study aims to study the impact of proton based sbrt on the kidney function.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. biopsy proven renal cell carcinoma. 3. no clinical or radiographic evidence of metastatic disease. 4. not a candidate for surgical treatment or local ablative procedures. 5. subjects are able to undergo either an mri or administration of contrast agent for ct. exclusion criteria: 1. prior history of radiation treatment with overlapping fields. 2. patients with proven metastatic disease. 3. female subjects who are pregnant or planning to become pregnant during the treatment.

Keywords: stereotactic body radiation therapy sbrt rcc
facbc for head and neck cancers

Conditions: Cancers of the Head and Neck

Summary: the purpose of this study is to assess a relatively new pet (positron emission tomography) radiotracer called facbc in the assessment of head and neck cancer. fdg (flourine deoxyglucose) is currently used for pet imaging, but has limitations in head and neck cancer. these limitations include problems with specificity, high background uptake from normal structures, difficulty delineating intracranial invasion, and the need to wait several weeks after chemotherapy and radiation before imaging. as an amino acid radiotracer, rather than a glucose radiotracer, facbc overcomes some of these limitations. facbc does not yet have fda (food and drug administration) approval, but does show promise in initial work in patients with prostate cancer and brain tumors. dosimetry work on facbc has been performed at emory. our study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical resection (ie, surgery without preceding chemotherapy or radiation). patients must have pre-surgical imaging, either with a contrast enhanced ct, fdg pet, or mri. patients who consent to participate will receive one facbc pet/ct of the neck, which will require a low dose "transmission" ct of the neck, an intravenous injection of the radiotracer, and imaging of the neck that will last up to 1 hour. patients will have to lie still during the imaging time. total participation time including set up should be less than 90 minutes. imaging results will be analyzed and compared with conventional imaging as well as the surgical pathology results


Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. biopsy proven, untreated squamous cell carcinoma of the oral cavity. 3. clinical, laboratory, or diagnostic imaging findings on ct, mri, or 18f-fdg pet/ct. 4. ability to lie still for pet scanning. 5. able to provide written informed consent. exclusion criteria: 1. age less than 18 years. 2. prior history of carcinoma. 3. not a candidate for surgical resection based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy. 4. inability to lie still for pet scanning. 5. inability to provide written informed consent.
reducing anxiety in children undergoing day surgery

Conditions: Anxiety; Child, Only; Surgery

Summary: aim: this study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. methods: the study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. the study was conducted between april 2023 and january 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. a total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between april 2023 and january 2024 and who met the inclusion criteria were included in the study. descriptive statistics, mann whitney u test, kruskal wallis and regression analysis were used in the evaluation of the data.

this study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. the study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods. the study was carried out from april 2023 to january 2024, involving children aged 6-12 years admitted to the pediatric clinic of a teaching and research hospital for day surgery (tonsillectomy, circumcisio, adenotonsillectomy etc.). notably, the nursing care provided at the hospital does not incorporate distraction techniques aimed at alleviating anxiety in children. sample the sample required for the study was calculated using the g\*power (3.1.9.4) computer program. based on the type i error of 5%, type ii error of 99%, sd = 6.20, and type i error of 5% in the study by dehghan et al. (2017), the desired effect size for this study was 0.55 and the total required sample size was 64 children (approximately 21 children for each group) (dehghan et al., 2017). a total of 85 children, comprising 20 children in the control group, 22 in the finger puppet intervention group, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group, was recruited from the pediatric clinic between april 2023 and january 2024, meeting the study's inclusion criteria. notably, no randomization method was employed in the selection process.

Eligibility criteria:
inclusion criteria: * children aged 6-12 years * scheduled for day surgery * devoid of prior surgical experiences * willingly consented to participation. exclusion criteria: * children undergoing major surgeries (e.g., cardiac procedures) * emergency surgical interventions * individuals with mental retardation * as well as those with visual or auditory impairments.

Keywords: anxiety child day surgery
study of the bruton's tyrosine kinase inhibitor in subjects with chronic graft versus host disease

Conditions: Graft Versus Host Disease

Summary: the purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory chronic graft versus host disease.


Eligibility criteria:
inclusion criteria: * steroid dependent or refractory classic chronic gvhd disease. * no more than 3 previous treatments for cgvhd. * receiving baseline systemic glucocorticoid therapy (at stable dose) for cgvhd at study entry. * men and women ≥18 years old. * karnofsky performance status ≥60. exclusion criteria: * known or suspected active acute gvhd. * current treatment with sirolimus and either cyclosporine or tacrolimus. * history of treatment with a tyrosine kinase inhibitor (eg, imatinib), purine analogs or other cancer chemotherapy in the 4 weeks prior to starting study drug. * currently active, clinically significant cardiovascular disease. * uncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ≤14 days before the first dose of study drug. * progressive underlying malignant disease including post-transplant lymphoproliferative disease. * history of other malignancy (not including the underlying malignancy that was the indication for transplant) * concomitant use of warfarin or other vitamin k antagonists * known bleeding disorders or hemophilia. * history of stroke or intracranial hemorrhage within 6 months prior to enrollment. * known history of human immunodeficiency virus (hiv) or active with hepatitis c virus (hcv) or hepatitis b virus (hbv). * concurrent use of a strong cytochrome p450(cyp) 3a inhibitor.

Keywords: pcyc1129 pcyc1129ca 1129 ibrutinib pci32765 imbruvica pharmacyclics pcyc gvhd steroid dependent refractory chronic graft versus host disease chronic graft versus host disease immunology
aprepitant for the relief of nausea in patients with chronic nausea and vomiting of presumed gastric origin trial

Conditions: Gastroparesis

Summary: the principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.

apron is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks. the symptoms will be measured with the gastroparesis cardinal symptom index daily diary (gcsidd) for one week at baseline and for four weeks after randomization. in addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (vas) for one week at baseline and daily for four weeks after randomization. there will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.

Eligibility criteria:
inclusion criteria: * age 18 years or older at registration * gastric emptying scintigraphy within 2 years of registration * normal upper endoscopy or upper gi series within 2 years of registration * symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with gastroparesis cardinal symptom index (gcsi) score of greater than or equal to 21 * significant nausea defined with a visual analog scale (vas) score of greater than or equal to 25 mm on a 0 to 100 mm scale exclusion criteria: * another active disorder which could explain symptoms in the opinion of the investigator * use of narcotics more than 3 days per week * significant hepatic injury as defined by significant alanine aminotransferase (alt) and aspartate aminotransferase (ast) elevations of greater than 2x the upper limit of normal (uln) or a child-pugh score of 10 or greater * contraindications to aprepitant such as hypersensitivity or allergy * concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride * pregnancy or nursing * any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study * failure to give informed consent

Keywords: gastroparesis nausea vomiting
long term safety and efficacy of pasireotide s.c. in patients with cushing's disease

Conditions: Cushings Disease

Summary: this is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with cushing's disease. patients with cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. for this study, each enrolled patient will be followed up for 3 years after enrollment. patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.


Eligibility criteria:
inclusion criteria: * written informed consent or equivalent document (e.g., written information) as per country regulation prior to registration of any patient data * male or female patients aged 18 years or older with a diagnosis of cushing's disease for whom surgery has failed or for whom surgery is not an option * patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry exclusion criteria: * patients with ectopic acth-dependent cushing's syndrome * patients with adrenal cushing's syndrome * patients with pseudo cushing's syndrome

Keywords: cushing's disease, pasireotide s.c. signifor
the effect of acute mild dehydration on blood pressure control

Conditions: Mild Dehydration

Summary: the goal of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. this protocol will test healthy young and older adults in a normally hydrated and dehydrated condition.

the purpose of this project is determine how acute mild dehydration impacts blood pressure control at rest and during static exercise. additionally, we will determine whether or not the sympathetic nervous system has a role in mediating blood pressure control at rest and during static exercise. this protocol will test healthy young and older adults in a normally hydrated and dehydrated condition. this will allow for a within participant comparison. additionally, we will later determine if age alters blood pressure control at rest or during static exercise.

Eligibility criteria:
inclusion criteria (young): • age: 20-35 years old exclusion criteria (young): * high blood pressure (\>140/90 mmhg) * history of cardiovascular disease * history of cancer * history of diabetes * history of kidney disease * obesity (bmi \> 30 kg/m2) * smoking or tobacco use * current pregnancy * nursing mothers * communication barriers inclusion criteria (older): * age: 60-75 years old * ecg within normal limits * screening blood panel within normal limits exclusion criteria (older): * high blood pressure (\>140/90 mmhg) * history of cardiovascular disease * history of cancer * history of diabetes * history of kidney disease * obesity (bmi \> 30 kg/m2) * smoking or tobacco use * current pregnancy * nursing mothers * communication barriers

Keywords: dehydration
characterization of the adherence threshold for hiv suppression of a kaletra-based regimen

Conditions: HIV Infection

Summary: the hypothesis of this study is that the level of adherence necessary to achieve hiv virologic suppression with a ritonavir boosted protease inhibitor regimen (i.e. lopinavir/ritonavir) is less than the 95% rate observed in the published literature with unboosted regimens.

the existing dogma is that patients receiving highly active antiretroviral therapy (haart) to treat their hiv infection must take at least 95% of prescribed doses in order to maintain full suppression of viral replication. this belief is largely based on a single study that was performed between 1997 and 1999 (ann int med 2000;133:21-30). the vast majority of patients in this study were receiving regimens based on either indinavir, nelfinavir, ritonavir, or saquinavir. all of these agents have relatively short half-lives, and therefore must be taken on time two or three times per day. newer medications such as lopinavir/ritonavir (kaletra) feature much more favorable pharmacokinetic profiles. on the basis of improved pharmacokinetics, there is reason to believe that regimens built around such agents may be more forgiving of missed medication doses. this study aims to enroll 90 patients from the mmc i.d. clinic who are either receiving or are about to receive kaletra. patients who agree to participate will be furnished with a mems cap, a bottle cap that electronically records each time that the bottle is opened and stores the data for computer download, and will undergo electronic monitoring of their kaletra adherence for a period of siz months. adherence data will not be reviewed during the study, but at study end (and at interim time points), the investigators will analyze the mems cap data from patients who have completed the study in order to determine the threshold value of adherence necessary to achieve satisfactory rates (i.e. 70-80%) of complete virologic suppression. an additional aim of the study is to collect specimens from patients receiving kaletra based regimens who experience virologic failure and to archive them for possible studies of genotypic and phenotypic resistance in the future.

Eligibility criteria:
inclusion criteria: * hiv infection * receiving twice daily kaletra at an fda approved dosage * age\>18 years * cd4 and viral load available within seven day of enrollment * patient willingness to accept mems cap monitoring * hiv genotype within 60 days of enrollment for patients with viral load\>1000 * patient willingness to grant informed consent and complete five study visits exclusion criteria: * provider or patient deem it unlikely that kaletra therapy will continue for the ensuing 24 weeks * prescription of any medication that is contraindicated for kaletra recipients

Keywords: hiv adherence antiretroviral therapy protease inhibitor lopinavir
comparative presence of piriformis syndrome in patients with lumbar disc bulging and protrusion

Conditions: Piriformis Syndrome

Summary: clinicians consider lumbar disc herniation more prominently in the differential diagnosis than piriformis syndrome, as it is the most common cause of sciatica, and this canalizes them to overlook that the sciatic nerve may be compressed by the piriformis muscle, below the l4-l5-s1 intervertebral disc levels. as far as is known, there are no 'patient series' in the literature regarding the incidence of piriformis syndrome in lumbar disc herniation, only one case report has been found. this clinical study aims to reveal that piriformis syndrome may also be present in patients with disc herniation on magnetic resonance imaging (mri), and that sometimes it may even be the main cause of sciatic nerve pain.

in this study, the participants between the ages of 18-65, who were diagnosed with l4-l5 and/or l5-s1 lumbar disc herniation (bulging and protrusion) by having a lumbar mri at the faculty of medicine sports medicine outpatient clinic, were reached through their contact numbers, and those who had not previously undergone waist/hip surgery and those who described unilateral sciatica complaints (hip-leg-foot pain and numbness) during the interview were invited to yüzüncü yıl university faculty of medicine sports medicine polyclinic and lasegue's, flexion adduction internal rotation (fair) and freiberg's tests were performed.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * having unilateral sciatica * having disk herniation in the form of bulging or protrusion in a previous lumbar magnetic resonance imaging (mri) exclusion criteria: * having bilateral sciatica * having disc herniation in the form of extrusion or sequestration in a previous lumbar magnetic resonance imaging (mri) * previous back and/or hip surgery
rheumatoid arthritis patients on adalimumab to evaluate its effect on synovitis using ultrasonography in an egyptian population

Conditions: Rheumatoid Arthritis

Summary: this post-marketing observational study (pmos) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with rheumatoid arthritis (ra) in egypt. b-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-tnf) therapy in the past.

this study was a prospective, observational, single arm, multicenter study. participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. a total of 5 visits were planned: baseline (visit 1), visits 2, 3, 4 and 5 (week 13). the time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. additional study objectives were to investigate the rate of ra progression via changes in the b-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. the study was terminated due to low enrollment.

Eligibility criteria:
inclusion criteria: a patient will be enrolled in this study if he/she fulfills all of the following criteria: * male or female patients ≥ 18 years of age with diagnosis of ra * patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines * patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-cd4) and anti-tnf treatments at the start of the study * patient has no history of inflammatory arthritis other than rheumatoid arthritis * patient has no history of lymphoma or leukemia or other malignancies * has negative result of tuberculosis (tb) screening test or is receiving tb prophylaxis as per local guidelines, provided written authorization to the investigator to use and/or disclose personal and/or health data, or informed consent if requested by the local regulations exclusion criteria: * patients that are not diagnosed with rheumatoid arthritis as judged by the american college of rheumatology criteria * patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression * susceptibility to infections including tb, as judged by the investigator * patient is carrier of hepatitis b virus * patient is a pregnant or lactating female at the time of screening

Keywords: synovitis rheumatoid arthritis
prevalence of microalbuminuria among children suffering from sickle cell nephropathy and sickle cell/beta-thalassemia

Conditions: Sickle Cell Anemia; Beta-Thalassemia; Microalbuminuria

Summary: sickle cell nephropathy is a known complication of sickle cell anemia (sca) manifested by increase in glomerular filtration rate (glomerular hyperfiltration) and results in proteinuria and chronic renal failure. our goal is to examine the prevalence of proteinuria and microalbuminuria as an early predictive factor of glomerular injury, among young people who suffer from sca as well as those who suffer from combined sickle cell/beta-thalassemia.


Eligibility criteria:
inclusion criteria: * patients diagnosed with sickle cell anemia * patients diagnosed with combined sickle cell anemia/beta-thalassemia exclusion criteria: * diabetes mellitus * hypertension * reduced renal mass (single kidney) * overweight * history of utis