Kornimate/medical-research-clean huggingface dataset:
iccare consortium pilot project 1: feasibility of a point of prostate cancer diagnosis intervention for newly diagnosed black men

Conditions: Prostate Carcinoma

Summary: this study is being done to determine the acceptance and effectiveness of a virtual robot assistant model at a urology clinic.

primary objectives: i. plan and develop a ppcd iccare vira model that will provide social determinants of health (sdoh) navigation services, psycho-oncology support and emotional support using qualitative formative research. ii: establish the acceptance and usability of the iccare vira at a urology clinic among 50 black men (bm). outline: this is an observational study. participants are assigned to 1 of 5 cohorts. cohort i: consumer advocates attend a focus group on study. cohort ii: clinicians complete interviews on study. cohort iii: iccare project representatives test the virtual health intervention, complete a survey, and attend a focus group on study. cohort iv: non iccare affiliated member tests the virtual health intervention, complete a survey, and attends a focus group on study. cohort v: patients complete surveys and participate in the virtual health intervention on study. patients complete survey and an interview during follow up.

Eligibility criteria:
inclusion criteria: * aim 1: iccare consortium consumer advocates, clinicians as part of the iccare consortium translational research \& clinical intervention services core, and non-iccare affiliated member. * aim 2 alpha testing: 1 representative from each of the other iccare five projects and six cores/services and 1 non iccare affiliated member * aim 2 beta testing-patients: * a black male * a patient who has been diagnosed with prostate cancer in florida * have an abnormal psa and/or dre lab value within the previous 6 months * minimum age of 30 yrs * consent to participating in the intervention exclusion criteria: * aim 2 beta testing-patients: * patients who are not black males * not patients at a urology clinic * have normal psa and/or dre lab values within the previous 6 months * older than 80 yrs * are not willing to consent
safety of capsule endoscopy in patients with implantable cardiac devices

Conditions: Gastrointestinal Disease; Anemia

Summary: this is a prospective study designed to assess safety and potential influence of the mirocam on cardiac pacemaker and implantable cardiac defibrillator.

mirocam (intromedic, ltd, seoul, korea) is a small bowel capsule endoscope using human body communication for data transmission. there is a concern of potential interactions between cardiac devices and capsule endoscope. this clinical study was designed to evaluate the potential influence of the mirocam on cardiac pacemaker and implantable cardiac defibrillator.

Eligibility criteria:
inclusion criteria: 1. age 20 years or older 2. cardiac pacemaker or implantable cardiac defibrillator 3. gastrointestinal disease exclusion criteria: 1. previous gi perforation or obstruction history 2. known or suspected gi stricture 3. marked gi dysmotility 4. uncompensated heart failure (ef ≤30% or killip's classification class ≥ iii) 5. pregnancy

Keywords: capsule endoscopy cardiac pacemaker implantable cardiac defibrillator
vaginal dinoprostone administration prior to an intrauterine device insertion in multiparous women.

Conditions: IUD Insertion

Summary: to investigate whether vaginal dinoprostone administered before intrauterine device (iud) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (iud) is attempted through a narrow cervical canal.iud insertion- related complications and side effects are more common among women who had never delivered vaginally. pain can be perceived during all steps of iud insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the iud introducer through the cervical canal inside the uterine cavity

Eligibility criteria:
inclusion criteria: * multiparous women aged over 18 years of age requesting an iud for contraception, had a negative pregnancy test. exclusion criteria: * currently pregnant or were pregnant within 6 weeks of study entry * had a prior attempted or successful iud insertion * had a history of a cervical procedure such as cone biopsy, loop electrosurgical excision procedure, or cryotherapy * any world health organization medical eligibility criteria category 3 or 4 precaution to an iud * active vaginitis or cervicitis * undiagnosed abnormal uterine bleeding * pelvic inﬂammatory disease within the last 3 months * ﬁbroids or other uterine abnormalities distorting the uterine cavity * contraindication or allergy to dinoprostone.
a study of olezarsen (formerly known as akcea-apociii-lrx) in adults with hypertriglyceridemia and atherosclerotic cardiovascular disease (established or at increased risk for), and/or with severe hypertriglyceridemia

Conditions: Hypertriglyceridemia; Atherosclerotic Cardiovascular Disease; Severe Hypertriglyceridemia

Summary: the purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (tg) levels compared to placebo at months 6 and 12 and the percentage of participants who achieve different thresholds in fasting tg. another objective is to evaluate the effect of olezarsen on percent change in fasting apolipoprotein c-iii (apoc-iii), very low-density lipoprotein cholesterol (vldl-c), remnant cholesterol, non-high-density lipoprotein cholesterol (non-hdl-c), hdl-c, total cholesterol (tc), apolipoprotein b (apob), low-density lipoprotein cholesterol (ldl-c), and apolipoprotein a-1 (apoa-1).

this will be a multi-center, randomized, double-blind, placebo-controlled study in approximately 152 participants with hypertriglyceridemia (triglycerides \> 150 milligrams per deciliter \[mg/dl\]) and established or at increased risk for atherosclerotic cardiovascular disease, and/or with severe hypertriglyceridemia. the study will have an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment follow-up period.

Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years at the time of informed consent 2. fall into at least 1 of the following groups (a or b): 1. hypertriglyceridemia with fasting tg ≥ 150 mg/dl (1.69 millimoles per liter \[mmol/l\]) and \< 500 mg/dl (5.65 mmol/l) with either clinical diagnosis of atherosclerotic cardiovascular disease (ascvd) or at increased risk for ascvd 2. severe hypertriglyceridemia with fasting tg ≥ 500 mg/dl (5.65 mmol/l). 3. participants must be on standard-of-care (soc), lipid-lowering medications per local guidelines. 4. participants must be willing to comply with diet and lifestyle recommendations as able. exclusion criteria: 1. diabetes with any of the following: 1. newly diagnosed within 12 weeks of screening 2. hemoglobin a1c (hba1c) ≥ 9.5% at screening 3. change in basal insulin regimen \> 20% within 3 months prior to screening 4. for participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to screening 2. acute coronary syndrome or stroke/transient ischemic attack (tia) within 6 months prior to screening 3. major surgery, peripheral revascularization, or non-urgent percutaneous coronary intervention (pci) within 3 months prior to screening, or upcoming planned major surgery or major procedure (e.g., arterial revascularization) during the course of the study 4. active pancreatitis within 4 weeks prior to screening
cyanoacrylate use in free gingival graft

Conditions: Gingival Recession, Localized

Summary: present study aims to reveal the effects of cyanoacrylate application at the recipient bed and the donor site in free gingival graft surgery on the healing parameters and patient-based outcomes.


Eligibility criteria:
inclusion criteria: * single-tooth gingival recession in the anterior mandibular region * pain with chewing or oral hygiene practice * ongoing recession exclusion criteria: * systemic disease * smoking * pregnancy / lactation
garlic oil as root filling material in primary molars

Conditions: Irreversible Pulpitis (toothache)

Summary: the goal of this study is to test garlic oil mixed with zinc oxide as a potential root canal filling material of primary molars in children aged from four to eight years. the study hypothesized that garlic oil mixed with zinc oxide would be the same as the gold standard filling material (metapex). the group receiving the garlic oil with zinc oxide as root canal filling material will be compared with other similar group receiving metapex as root canal filling material in terms of clinical and radio-graphic success, and working time.

this study is a randomized clinical trial (rct), that aims compare the clinical and radio-graphic success of garlic oil mixed with zinc oxide, used as root canal filling material in primary molars in children aged from four to eight years, with the conventional root filling material, which is metapex.

Eligibility criteria:
inclusion criteria: 1. primary second molars which are diagnosed with irreversible pulpitis, or pulp necrosis. 2. presence of sinus tract. 3. periapical bone swelling. 4. continuous bleeding after amputation of the coronal pulp tissue. 5. no pulp tissue remains when the pulp chamber is accessed. 6. pus discharges from the canal. 7. radiographically, only primary molars with at least two-thirds of the root length. 8. presence of inter-radicular or periapical radiolucency. exclusion criteria: 1. a tooth with internal root resorption will not be included. 2. excessive tooth mobility beyond healing. 3. carious perforation in the pulpal flour. 4. a tooth with a pathological lesion extending to the successor's tooth germ. 5. non-restorable primary molars. -

Keywords: rct garlic oil natural remedies primary molars root canal filling material
topical anesthesia for removal of stitches after total knee arthroplasty

Conditions: Metal Staple Removal After Total Knee Replacement

Summary: lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement

this is a double-blind randomised control trial. after informed consent, the patients who undergoes primary total knee replacement will be assigned to either control group or experimental group randomly. the effectiveness and complication will be analysed. if the patients are not medically fit for the study (including contraindications for lidocaine), they will be excluded.

Eligibility criteria:
inclusion criteria: 1. males and females, aged 50-100 years 2. the patients who undergo primary total knee replacement (performed by the same surgeon, dr.jiang) 3. clear consciousness 4. no contraindication for staple removal on the post-operative day 7 exclusion criteria: 1. allergy to lidocaine 2. patient with second or third degree atrio-ventricular block 3. patients with severe sinoatrial node block 4. patients taking class i antiarrhythmia drugs 5. pregnant patients 6. patients undergoing revision total knee replacement 7. contraindication for removal of staples on post-operative day 7

Keywords: total knee replacement stitch removal pain
septic shock and delirium because of rso2 abnormalities in intensive care unit patients (the sad brain study)

Conditions: Septic Shock; Delirium; Renal Failure

Summary: delirium in the icu is a prevalent problem occurring in up to 80% of icu patients. a potential cause of delirium in icu patients could be cerebral hypoxia. septic shock is associated with high rates of delirium. the aim of this pilot study is two fold. first, to determine the feasibility and potential challenges of measuring cerebral oxygenation in icu patients with severe sepsis and septic shock. and second, to see if the incidence and magnitude of cerebral desaturations correlated with icu acquired delirium as measured by the confusion assessment method (cam) scores.


Eligibility criteria:
inclusion criteria: * over 18 * diagnosis of septic shock * require mechanical ventilation and vasopressor therapy exclusion criteria: * previous stroke * dementia * recent craniotomy
fast brain mri in children with suspected brain tumor

Conditions: Magnetic Resonance Imaging; Brain Neoplasms, Childhood; Brain Neoplasms; Brain Tumor; Diagnosis; Image; Neuroimaging; Pediatric

Summary: this study aims to assess the diagnostic performance of a new fast mri sequence named neuromix compared to routine clinical mri for brain tumor in pediatric patients

the study aims to assess the diagnostic performance of fast mr sequence for the radiological evaluation of brain tumor in comparison to routine clinical mri (or reference standard) in a pediatric population. the primary outcome is the depiction and characterization of normal brain, brain tumor pathology and incidental findings. sensitivity, specificity, auc and intra-/ interreader agreement for the diagnostic performance of neuromix compared to cmri will be obtained. correlation of results between methods will be calculated. secondary outcomes will also include the assessment of diagnostic image quality and image artifacts. the study population will consist of subjects aged 0-18 with a suspected or diagnosed brain tumor referred for routine mri examination of the brain. study subjects will be investigated during the same day at 3t mr with neuromix sequence in addition to the routine mri examination. volume measurements will be compared.

Eligibility criteria:
inclusion criteria: * age 0-18 years. * pediatric subjects with diagnosed or suspected brain tumor * referral routine mri study. exclusion criteria: * mri planned without sedation * aborted mr exam * unstable patient

Keywords: neuro imaging mri diagnostic accuracy neuroimaging fast mri neuromix pediatric
functionality and clinical correlates in tmd

Conditions: Temporomandibular Disorders (TMD); Functional Limitation; Pain Severity; Neck Disability; Quality of Life

Summary: temporomandibular disorders (tmd) are among the most common causes of orofacial pain and refer to structural and functional impairments related to the masticatory muscles, surrounding soft tissues, and/or the temporomandibular joint (tmj). they negatively affect individuals physically, psychologically, and socially. the structural and functional impairments observed in tmd typically manifest as pain, restricted jaw movement, joint sounds, and muscle tension. in addition to these core symptoms, secondary issues such as chewing difficulties may also occur. pain in tmd can negatively impact many orofacial functions, especially chewing. functional impairment in individuals with tmd may result from pain, restricted jaw mobility, muscle tension, alterations in muscle activation, mandibular asymmetry, and morphological changes in the joint. these findings highlight the importance of addressing factors associated with functional impairment in individuals with tmd. pain severity is strongly associated with functional limitations of the tmj and neck disability. particularly in cases of muscular-origin tmd, significant impairments in neck muscle function and joint mobility have been observed. this condition directly affects jaw function and leads to a decrease in quality of life. the impact of tmd on quality of life is directly related to pain severity and functional limitations. as pain severity increases, limitations in daily activities and reductions in overall quality of life also increase. therefore, a multidisciplinary approach to tmd is essential for pain management, functional rehabilitation, and improving quality of life. the aim of this study is to investigate the relationships between functionality and pain, range of motion, neck disability, and quality of life in individuals with tmd. understanding these relationships will form a basis for the effective management of tmd and improving individuals' quality of life.


Eligibility criteria:
inclusion criteria: * voluntary participation in the study * aged between 18 and 55 years * diagnosed with temporomandibular disorders (tmd) and exhibiting at least one of the three main symptoms (jaw pain, limited mouth opening, and/or temporomandibular joint sound) * a mini-mental state examination (mmse) score of 24 or higher * pain score of 3 or above on the visual analog scale (vas) exclusion criteria: * history of complex surgery, trauma, chemoradiotherapy, and/or tumors involving the head and neck region * ongoing use of analgesics, anti-inflammatory or psychiatric medications, and/or substance abuse * significant tooth loss that interferes with chewing function * use of dental prosthesis * ongoing tooth pain * receiving any tmd-specific treatment prior to or during the evaluation period * history of orthodontic treatment * diagnosis of disc displacement without reduction
fecal microbiota transplantation (fmt) in metastatic melanoma patients who failed immunotherapy

Conditions: Melanoma Stage Iv; Unresectable Stage III Melanoma

Summary: altering the gut microbiota of melanoma patients who failed immunotherapy using fecal microbiota transplantation (fmt) from responding patients. fmt includes both colonoscopy and stool capsules.

this is a phase i single-center study of fecal microbiota transplant (fmt) in melanoma patients who failed at least one line of pd-1 blockade. eligible patients must have a disease amenable to biopsy and lack of contra-indications to fmt. patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study. eligible patients will undergo fmt. the fmt includes a colonoscopy followed by stool capsules. patients will undergo repeated evaluations including follow-up blood, stool and radiological testings. the study will be conducted over a 24-week period.

Eligibility criteria:
inclusion criteria: * a histologically confirmed diagnosis of metastatic melanoma. * failed at least one line of pd-1 blockade. * ecog performance status 0-2 * able to provide written informed consent. exclusion criteria: * presence of absolute contra-indications to fmt administration. * severe dietary allergies (e.g. shellfish, nuts, seafood). * anatomic contra-indications to colonoscopy. * inability to swallow capsules. * current participation in a study of an investigational agent. * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. * history of bleeding disorder, chronic kidney disease, inflammatory bowel disease. * history of a major abdominal surgery * is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.

Keywords: melanoma fecal microbiota transplantation immunotherapy
implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis

Conditions: Liver Cirrhosis

Summary: the study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).


Eligibility criteria:
inclusion criteria: * diagnosis of liver cirrhosis according to current protocols. * conscious and cooperative adult patients. exclusion criteria: * patients with hemodynamic and/or respiratory instability. * patients with contraindications for colonoscopy or fecal transplantation. * patients with acute or chronic infections with hiv, tuberculosis, mdr enterobacteria, cmv, parasites, fungi. * associated oncological pathology. * patients with other causes of severe immunodeficiencies. * lack of compliance with the conditions imposed by the research project. * patients who do not sign the informed consent.
effect of sodium bicarbonate, saline and black mulberry syrup on degree of oral mucositis in children receiving chemotherapy

Conditions: Oral Mucositis; Chemotherapy Effect

Summary: this study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.

oral mucositis, also known as stomatitis, is the most common complication of cancer treatment. mucositis affects the patient's nutrition, daily functions, and quality of life, may compromise the ability to tolerate scheduled therapy. for this reason, the children to be included in the study will be randomly divided into three groups. sodium bicarbonate, which is the routine care in the clinic, will be administered to the control group, and to the intervention groups, saline in addition to the routine care and black mulberry syrup will be applied in addition to the routine care. data will be collected according to patient information form, international child mucositis assessment scale (chimes), world health organization mucositis classification and neutrophil counts. oral care will be applied to the groups 4 times a day for 14 days. the international child mucositis rating scale (chimes), world health organization mucositis classification and neutrophil counts will be evaluated by the researchers on the 1st, 2nd, 4th, 8th and 16th days.

Eligibility criteria:
inclusion criteria: * the willingness of the family and the child to participate in the study * parent and child have separately informed written consent form * be between 6-18 years old * receiving chemotherapy and being hospitalized for chemotherapy treatment * being fed orally exclusion criteria: * oral mucositis in the first intraoral evaluation * having diabetes * receiving radiotherapy * having a surgical procedure in the mouth and jaw area * receiving steroid therapy during chemotherapy treatment * using a method other than the methods used in the study to protect the oral mucous membrane throughout the study

Keywords: sodium bicarbonate saline black mulberry syrup oral mucositis chemotherapy children
evaluation of the impact of pancreatectomy on systemic immunity

Conditions: Pancreas Cancer; Pancreatectomy; Hyperglycemia

Summary: the study aims at establishing the profile of the immune reaction that occurs in the early surgical suites after pancreatectomy. blood samples will be collected before surgery, (day-1), at day0, and after surgery at day 1, day 3, day 7 at 1 year after pancreatectomy. mass cytometry, genomic and transcriptomic approaches will be used to evaluate the immune systemic modulation after surgery.


Eligibility criteria:
inclusion criteria: * patient with an indication of pancreatectomy * signed consent form exclusion criteria: * neoadjuvant treatment * pregnancy

Keywords: pancreatectomy immune system