Kornimate/medical-research-clean huggingface dataset:
frequency and risk factors for autoimmune disorders and rheumatic manifestations in egyptian patients with ibd

Conditions: IBD

Summary: to examine the prevelance of autoimmune disorders and rheumatic manifestations in egyptian patients with inflammatory bowel diseases,and asses the relation between prevelance of autoimmune disorders ,rheumatic manifestations and disease activity of ibd


Eligibility criteria:
inclusion criteria: * 1-adult patients with adiagnosis of ibd according to the validated criteria. 2-patients\>18 years without aprevious diagnosis of spa or other rheumatological manifestations. exclusion criteria: * 1- patients with active cancer or lymphoproliferative disease. 2-patients with uncontrolled diabetes. 3-patients with unstable ischeamic heart disease or congestive heart failure. 4-patients with acute renal failure. 5-patients already diagnosed with inflammatory or crystal induced arthropathies (including gout and calcium pyrophosphate dehydrate deposition disease) or other autoimmune diseases.
exploring the role of palliative care in phase 1 enrolled pediatric oncology patients

Conditions: Quality of Life

Summary: this study is being conducted to learn more about the patient/family experience when opting to enroll in phase i clinical trials and their quality of life (qol) while receiving experimental therapy. palliative care (pc) has the potential to be beneficial for these families and further studies are needed to determine the most effective way for integration of pc into the care of patients enrolled on experimental clinical trials. primary objective * to qualitatively assess the patient and family experience, their hopes and worries and associated distress while deciding to enroll on a phase i clinical trial.

eligible parent research participants (prps) who consent will participate in one audio recorded interview in which they are asked about 8-10 questions. the interview can be conducted in person, over the phone, or webex/zoom (audio only). the interview will last about 30 to 60 minutes. prps can opt to complete interviews immediately or at a scheduled date that is convenient to the prp.

Eligibility criteria:
inclusion criteria: * caregiver is 18 years of age or older * caregiver is related to the patient in one of the following ways: biological parent, stepparent, or primary legal guardian * if more than 1 set of parents are involved in the patient's care (e.g., 2 biologic and 2 stepparents or partners) involved, the caregiver with legal decision- making responsibilities will be eligible for participation * caregiver is comfortable speaking and reading english exclusion criteria: * those who do not meet inclusion criteria

Keywords: palliative care pediatric oncology patients caregiver phase i studies associated distress hopes worries
patient reported outcomes in adults with pediatric-onset hypophosphatasia treated with strensiq® (asfotase alfa)

Conditions: Hypophosphatasia

Summary: this observational study will evaluate the treatment effect of strensiq (asfotase alfa) on patient reported outcomes (pros) in participants diagnosed with pediatric-onset hypophosphatasia (hpp) registered in the patient support program managed by onesource™.

participants consenting to participate in this study will be asked to complete study questionnaires by phone interviews upon consenting (baseline), and up to 12 months following treatment initiation with asfotase alfa. demographic and clinical characteristics of participants in the study will be characterized. this is an observational study and no intervention will be administered. participants will be treated in accordance with standard of care.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * clinical diagnosis of pediatric-onset hpp * naïve to asfotase alfa * expected to begin treatment with asfotase alfa for hpp * registered in onesource * willing and able to provide voluntary, verbal informed consent to participate in this study exclusion criteria: * pregnant or breastfeeding * unable to speak and understand english * unable or unwilling to complete the study surveys via telephone interview at the protocol-required time points

Keywords: pediatric-onset hypophosphatasia pediatric-onset hypophosphatasia hpp patient reported outcome
endoscopically placed lumen-apposing metal stents for the treatment of symptomatic intestinal strictures in individuals with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Stricture; Bowel

Summary: this is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of lams with respect to symptom and quality of life improvement and the development of stent-related complications.

this will be a prospective case series study in \~20 ibd patients with symptomatic partially-obstructing intestinal strictures \&lt; 6 cm in length without severe active inflammation (large or deep ulcers at distal entrance or moderate-severe friability or severe inflammatory changes in the stricture on radiographic imaging, at the discretion of the referring ibd physician or treating therapeutic endoscopist) or penetrating complications (pre-stenotic fistula or intra-abdominal phlegmon or abscess), evaluating the use of lams with respect to symptom and quality of life improvement and the development of stent-related complications. the objective of this project is to evaluate the safety and efficacy of lams for the treatment of short segment, symptomatic, ibd-related strictures. the hope is that positive results from this pilot study will provide sufficient rationale to trigger a larger scale multicenter study to fully assess the efficacy of endoscopic stenting for ibd-related strictures.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * established diagnosis of inflammatory bowel disease * symptomatic, single, fibrostenotic or anastomotic stricture \&lt;6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum) * ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques * able to provide informed consent exclusion criteria: * more than one intestinal stricture * stricture out of reach of standard adult colonoscope * high-grade stricture (complete or near complete bowel obstruction * severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess * contraindications for endoscopic therapy, including: * complete bowel obstruction * severe cardiorespiratory comorbidity * unable to tolerate sedation or anesthesia * non-reversible coagulopathy
treatment of androgenetic alopecia in males and females

Conditions: Androgenetic Alopecia

Summary: the purpose of this study is to evaluate the efficacy of low level laser and light therapy system configured in a novel product called the tophat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.


Eligibility criteria:
inclusion criteria: * diagnosis of androgenetic alopecia * fitzpatrick skin phototypes i-iv * norwood-hamilton iia to v for males and ludwig i or ii for females * active hair loss within the last 12 months * willingness to refrain from using all other hair growth products or treatments * in overall general good health as determined by the physician investigator exclusion criteria: * photosensitivity to laser light and non-laser led light operating at 655nms. * malignancy in the target treatment area * other forms of alopecia of the head * past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp * unwillingness to remove hair replacement products during the therapy sessions * using any medications deemed to inhibit hair growth as determined by the physician investigator
collecting recorded videos of colonoscopy tests

Conditions: Colon Polyp

Summary: the study shall mainly help to better evaluate the performance the apds device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon polyps.

primary objectives: to evaluate, in objective way, the usability of the future alpha version of the apds device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of colonoscopy screening tests of the general population. secondary objectives: when the apds would be ready for field installation (beta version), to install it in the gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the apds performance.

Eligibility criteria:
inclusion criteria: * subjects must meet all the - criteria related to regular colonoscopy according to the standard of care at the gastroenterology department of the selected center, _in addition the following - criteria have to be met to be eligible for the study: 1. able to read, understand and provide written informed consent; 2. females or males - older than 18 years old exclusion criteria: * any of the following colonoscopy related exclusion criteria will exclude the subject from the study: 1. bleeding disorder or unacceptable risk of bleeding 2. terminal illness or life threatening malignancy
development of perioperative delirium prediction model

Conditions: Cardiovascular Surgery

Summary: postoperative delirium is an acute organic brain dysfunction that is commonly observed following cardiovascular surgery. it presents with acute and fluctuating changes in the level of consciousness, resulting in impaired cognitive function and perception. the incidence of delirium following cardiac surgery has been reported to range from 11.4% to 55%. in light of the challenges associated with treating delirium once it has manifested, it is imperative to prioritise the early recognition and prevention of this condition. the objective of this study was to develop a perioperative delirium risk prediction model for patients undergoing cardiovascular surgery.

postoperative delirium is associated with an increased incidence of postoperative complications, which in turn lead to cognitive dysfunction, increased mortality, and the need for long-term care. it is predicted in the literature that the early detection of delirium cases, of which 30% are known to be preventable, improves prognosis. accordingly, a prediction model based on the identification of delirium risk factors can categorise intensive care patients into distinct risk levels according to their probability of developing delirium, thus enabling healthcare professionals to ascertain the likelihood of delirium and implement suitable preventive measures. a review of the literature reveals the existence of numerous delirium prediction models designed to identify patients at high risk of developing delirium. however, there is a paucity of studies examining models for predicting delirium risk in the context of cardiovascular surgery. the objective of this study is to develop a delirium risk prediction model for the perioperative period in patients undergoing cardiovascular surgery.

Eligibility criteria:
inclusion criteria: * over 18 years old * previous cardiovascular surgery * no mental deficiency and visual and hearing impairment * participants' acceptance to participate in the research * the patient is not in coma (rass score between -3 and +4, gcs score of 10 and above) exclusion criteria: * cardiovascular surgery under emergency conditions * being diagnosed with delirium, dementia, psychiatric illness and taking medication for this reason before the surgery * serious conditions such as cardiopulmonary resuscitation during surgery * alcohol and drug addiction * duration of mechanical ventilation exceeding 36 hours * dying in the intensive care unit within 24 hours

Keywords: cardiovascular surgery delirium prediction model
the effect of probiotics on chronic kidney disease

Conditions: Chronic Kidney Disease; Probiotics; Renal Function

Summary: probiotics could attenuate renal function deterioration in ckd patients.

chronic kidney disease (ckd) is a global health issue that has a substantial impact on affected individuals. chronic inflammation, which is widely seen in ckd including long-term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk. inflammatory markers such as c-reactive protein, il-6, il-18, and tnf-α, are elevated in dialysis patients and can predict cardiovascular event and all-cause mortality. endotoxin is bacterial lipopolysaccharide, and makes up the outer membrane of gram-negative bacteria. endotoxin is also an important source and also a marker of inflammation in ckd. the natural intestinal microbiota is altered in ckd patients as an increase in aerobic bacteria such as e. coli and a decrease in anaerobic bacteria such as bifidobacterium. dysbiosis might contribute to the chronic inflammatory state in dialysis patients through endotoxemia, induction of the pro-inflammatory cytokine, and production of uremic toxins through fermentation of protein in the large intestine. probiotics containing bifidobacterium species and lactobacilli species could benefit the host by inhibiting the growth or epithelial invasion of pathogenic bacteria, enhancing the intestinal barrier function, and regulating the immune system. probiotics could suppress proinflammatory cytokines, such as tnf-α and il-6 . in addition, probiotics could improve renal function parameters in uremic rats and significantly lower levels of blood urea nitrogen in stage 3 and 4 ckd patients. the aim of the present study is to evaluate: 1. whether probiotics could retard the decline of renal function? 2. whether probiotics could change microbiota? 3. whether probiotics could reduce the serum levels of endotoxin and cytokines (tnf-α, il-6, and il-18)? 4. whether probiotics could improve the gastrointestinal symptoms in ckd patients? estimated glomerular filtration rate, stool microbiota, serum cytokines and endotoxin, and gastrointestinal symptoms of stage 3-5 patients are measured before and after intervention. the wilcoxon signed-rank and wilcoxon rank-sum tests were used to compare intra- and intergroup differences for continuous variables, as appropriate. a p value less than 0.05 was considered significant.

Eligibility criteria:
healthy volunteers: the criteria for healthy volunteers were: no hypertension (blood pressure\ 90), after signing the consent form, the stool samples will be collected. ckd patients: inclusion criteria: ‧stage 3-5 ckd patients, at least 20 years of age and regular follow-up for at least 6 months prior to enrollment. exclusion criteria: * pregnancy. * on immunosuppressive therapy. * active infectious condition. * acute kidney injury. * consuming other forms of probiotics. * taking antibiotics within 30 days prior to enrollment.
diagnosing respiratory disease in children using cough sounds 2

Conditions: Pneumonia; Bronchiolitis; Asthma Exacerbation; Croup; Reactive Airway Disease; Upper Respiratory Disease; Viral Lower Respiratory Tract Infections; Lower Respiratory Disease

Summary: the purpose of this prospective study is to evaluate the efficacy of the resappdx software application in the diagnosis of childhood acute respiratory disease, including pneumonia, bronchiolitis, asthma/reactive airways disease, croup, lower respiratory tract disease (lrtd), viral lower respiratory tract infection (vlrti), and upper respiratory tract disease (urtd).


Eligibility criteria:
inclusion criteria: * infant or child aged greater than 29 days up to and including their 12th birthday (infant and children pediatric subgroups as defined in guidance for industry and food and drug administration staff: premarket assessment of pediatric medical devices dated march 24, 2014) * presenting to the study site (an outpatient facility, an urgent care center, an emergency department, or inpatient ward within 24 hours of admission) with current signs or symptoms of respiratory disease including cough, wheezing, stridor, chest in-drawing/retractions, difficulty breathing, fast breathing, nasal congestion/rhinorrhea, abnormal lung sounds on exam or cyanosis/hypoxemia. * onset of symptoms within past 14 days * outpatient or inpatient within 24 hours of admission * coughing spontaneously or able to cough voluntarily exclusion criteria: * lack of a signed consent form from parent or legal guardian * lack of signed assent form for children aged 7 years or older who, in the opinion of the investigator, is able to provide assent based on their age, maturity or psychological state. * need for mechanical ventilatory support ((including invasive, cpap, or bipap)) or high flow nasal cannula * history of structural airways abnormalities, tracheobronchomalacia, or vocal cord abnormalities (e.g. laryngomalacia, tracheomalacia, or bronchomalacia) * any medical contraindication to voluntary cough, including the following (only enroll if coughing spontaneously): severe respiratory distress, history of pneumothorax, eye/chest/abdominal surgery in past 3 months, hemoptysis in the past month * too medically unstable to participate in study per treating clinician * subject previously enrolled in smartcough-c-2 study * tracheostomy present or tube placed
randomized controlled trial of can-2409 immunotherapy during active surveillance for prostate cancer (ulysses)

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the effectiveness of can-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. can-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. can-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. the hypothesis is that can-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. participants will be randomized to the can-2409 or control arm at a 2:1 ratio. both arms receive standard of care active surveillance evaluations.


Eligibility criteria:
inclusion criteria include: * histologically confirmed adenocarcinoma of the prostate * patients choosing active surveillance * patients meeting definition of nccn low risk, intermediate risk or patients having only one nccn high-risk feature * nccn low risk is defined as having all of the following: psa \< 10 ng/ml, gleason ≤ 6, t1-t2a * nccn intermediate risk is defined as having at least one of the following and no high risk features: psa 10-20 ng/ml, gleason score =7, t2b-t2c * high risk with a single high risk feature is defined as having only one of the following: psa\>20 ng/ml, gleason score 8-10, or t3a * excluded are those in the following risk groups: high risk with more than 1 high risk factor; locally advanced/very high risk=t3b-t4; metastatic: n1 or m1 * patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections. * ecog performance status 0-2 exclusion criteria include: * active liver disease, including known cirrhosis or active hepatitis * patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs * known hiv+ patients * regional lymph node involvement or distant metastases * other current malignancy (except squamous or basal cell skin cancers) * other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up * prior treatment for prostate cancer except turp. if prior turp, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator * patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride) * patients who had or plan to use adt or have history of an orchiectomy. * patients who are planning to undergo radical treatment for prostate cancer within 12 months. * known sensitivity or allergic reactions to acyclovir or valacyclovir

Keywords: immunotherapy tumor vaccine immuno-oncology cytotoxicity prostate cancer active surveillance
efficacy comparison of 2 low-dose atropine eye drops in vietnamese children myopia management

Conditions: Myopia

Summary: the goal of this clinical trial is to compare the efficacy of 2 low-dose atropine drops (0,01%; 0,05%) in vietnamese children. the main questions it aims to answer are: 1. how is the difference in efficacy among 3 groups: atropine 0,01% vs 0,05% vs spectacles? 2. how is the difference in side effects among 3 groups: atropine 0,01% vs 0,05% vs spectacles? 3. how is the difference in rebound phenomena between 2 atropine groups?

the study is prospective, comparative, open label. participants are vietnamese children. prescribing drops : 1 drops/eye/night/ 12 months wash-out: 12 months the atropine drops in this study are commercially available.

Eligibility criteria:
inclusion criteria: * myopic 2 eyes (se above from -0.75 d, astigmatism below -1.50d) * 8 - 13 years old * vietnamese, speaking vietnamese * bcva from 8/10 each eye exclusion criteria: * using any contact lens in less than 3 months * other eye diseases than myopia * history of eye trauma, surgeries * having chronic systemic diseases or having medications affecting eye. * having contraindications of atropine drops * pre-known allergies to atropine drops * undergoing another myopia control treatments

Keywords: myopia control low-dose atropin vietnamese children
a study to evaluate the efficacy and safety of dexycu® for the treatment of ocular pain associated with cataract surgery (2)

Conditions: Cataract

Summary: a phase 3, prospective, randomized, double-masked, placebo-controlled, parallel-design, multicenter study to evaluate the efficacy and safety of dexycu® for the treatment of ocular pain associated with cataract surgery


Eligibility criteria:
inclusion criteria: * male or female subjects at least 40 years of age scheduled for cataract surgery * best corrected visual acuity (bcva) of 20/30-20/200 in the study eye * must be considered by the investigator to have visual (va) acuity potential greater than 20/30 in the study eye. exclusion criteria: * use of any corticosteroids within 7 days prior to day 0 * injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days * score greater than "0" on the ocular pain assessment in the study eye at screening.