Kornimate/medical-research-clean huggingface dataset:
magnetic steering improves small bowel capsule endoscopy completion rate

Conditions: Capsule Endoscopy; Small Bowel Disease

Summary: patients referred for magnetically controlled capsule endoscopy (mce) in the participating center from june 2017 to november 2017 were prospectively enrolled. magnetic steering of mce was performed after standard gastric examination. capsule endoscopy completion rate (cecr), gastric transit time (gtt), pyloric transit time (ptt) and rapid gastric transit rate (gtt ≤ 30 min) were compared with the historical control group enrolled from january 2017 to may 2017.

background and aims: capsule endoscopy is currently available as a noninvasive and effective diagnostic modality to identify small bowel abnormalities, while the completion rate ranged from 75.1% to 95.6%. a novel magnetically controlled capsule endoscopy (mce) system could facilitate the capsule to pass through pylorus thereby reducing the gastric transit time (gtt). the investigators perform this study to determine the potential improvement in capsule endoscopy completion rate (cecr) under magnetic steering vs standard mode. methods: patients referred for magnetically controlled capsule endoscopy (mce) in the participating center from june 2017 to november 2017 were prospectively enrolled. magnetic steering of mce was performed after standard gastric examination. capsule endoscopy completion rate (cecr), gastric transit time (gtt), pyloric transit time (ptt) and rapid gastric transit rate (gtt ≤ 30 min) were compared with the historical control group enrolled from january 2017 to may 2017.

Eligibility criteria:
inclusion criteria: * adult patients aged over 18 * with gastrointestinal complaints * scheduled to undergo a capsule endoscopy for both stomach and small bowel exclusion criteria: * no surgical condition or refusing abdominal surgery to take out the capsule in case of capsule retention * implanted pacemaker, except the pacemaker is compatible with mri * other implanted electromedical devices or magnetic metal foreign bodies * pregnancy or suspected pregnancy

Keywords: magnetic steering mce cecr
a study to evaluate ibrutinib retention in chronic lymphocytic leukemia participants treated in a real world setting

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the purpose of this study is to describe the 2-year retention rate of ibrutinib treatment for chronic lymphocytic leukemia (cll) in italian routine clinical practice.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of chronic lymphocytic leukemia (cll) requiring treatment (iwcll \[international workshop on chronic lymphocytic leukemia\] criteria) * if alive, must sign an informed consent form (icf) allowing data collection and source data verification in accordance with italian requirements * participants with one of the following characteristics: a) participants starting ibrutinib treatment according to the summary of product characteristics (smpc) at enrolment or within 30 days starting from informed consent signature, as per routine clinical practice and independently of this non-interventional study; or b) participants who have started ibrutinib within 3 months before enrollment, according to the smpc, as per routine clinical practice and independently of this non- interventional study (including also participants who, by the time of enrollment, are not receiving ibrutinib) * if alive, must be able to read and write in italian and to understand and sign the icf exclusion criteria: * currently enrolled in any interventional clinical trial * currently enrolled in observational studies sponsored or managed by janssen company * treated with any investigational compound or any invasive investigational medical device within 30 days before start of ibrutinib treatment * having contraindications to ibrutinib use as described in the smpc * pregnant or breast-feeding
coaching for confidence: evaluating an internet-based program to help parents help children with difficulty with anxiety

Conditions: Anxiety Disorders

Summary: the study is an open trial to evaluate a web-based intervention. the intervention focuses on supporting parents to help their children to overcome problems with anxiety. the children who are the focus of the study are in the age ranges of 4 - 12 and experience problems with separation anxiety, social anxiety, or generalized anxiety as identified by their parents. the program will exclude obsessive-compulsive disorder and post-traumatic stress disorder that are seen less often in this age group and require somewhat different interventions.

parents will be recruited for the study through stories in the media and notices sent through the schools to parents of school age children. the information will invite parents to contact the study staff if in their view their child is more anxious, fearful, shy or worried than most children of their age. parents will be screened to insure that the child's problem is appropriate for the study. if the child and family are judged to be appropriate for the study they will be provided a user name and password to access a web-based program called coaching for confidence. in the first part of the program they review the consent form and decide if they wish to provide consent. if they provide consent they complete initial assessment measures describing their child and themselves. once the assessment is completed they have access to the program through the internet. they are encouraged to complete the program over a period of 10 weeks. the program focuses on supporting the parent's understanding of child anxiety and the strategies they can take in helping their child to overcome limitations related to anxiety.

Eligibility criteria:
inclusion criteria: * diagnosis of social anxiety, separation anxiety, or generalized anxiety disorder * judged by parent to have anxiety that interferes with functioning in the home or school. * judged by clinician to have anxiety that interferes with functioning in the home or school. * parent unable to read and write in english. * parent unable to access the internet regularly - at least once a week exclusion criteria: * diagnosis of obsessive compulsive disorder * diagnosis of post-traumatic stress disorder * diagnosis of school refusal and not attending school at least half of the time * diagnosis of selective mutism * diagnosis of autism spectrum disorder * diagnosis of pervasive developmental disorder * child currently receiving psychosocial treatment for anxiety

Keywords: child behavior therapy cognitive therapy parent anxiety
amb dose for cryptococcal meningitis

Conditions: Cryptococcal Meningitis; HIV Infections

Summary: cryptococcal meningitis (cm) is one of the leading opportunistic infections and one of the most common causes of death in aids patients. amphotericin b (amb) is the corner stone in cm treatment. the effect of amb was dose-dependent. recent retrospective study indicated that longer duration rather than higher dose of amb is necessary to reduce the mortality of cm. we aimed to explore the efficacy and safety of small dose but longer duration of amb for the treatment of hiv-associated cm.


Eligibility criteria:
inclusion criteria: * confirmed hiv infection * naive to antiretroviral therapy * cryptococcal antigen, smear or culture positive in cerebrospinal fluid * agree to participate the study exclusion criteria: * having receiving antifungal treatment for ≥3 days * alt or ast \> 5\* upper limit of detection (uld), or neutrophil\ uld * pregnancy or breastfeeding * concomitant medications that are contraindicated with any research drug * any other contraindications for using amphotericin b or 5fc * inability to follow-up as accessed by the investigator

Keywords: hiv infection cryptococcal meningitis amphotericin b
study of phosphatidylcholine in a patient with methionine adenosyltransferase deficiency

Conditions: Methionine Adenosyltransferase Deficiency; Metabolism, Inborn Errors

Summary: objectives: i. determine whether plasma choline and breast milk choline levels are low at fasting in a patient with methionine adenosyltransferase deficiency, and if the choline levels are low, determine whether choline levels respond to dietary supplementation with phosphatidylcholine. ii. determine whether this patient has a fatty liver by magnetic resonance spectroscopy.

protocol outline: blood is drawn for liver function tests and measurement of plasma choline levels and breast milk samples are taken for measurement of breast milk choline levels at fasting and at 1 hour after breakfast on day 1. the patient then undergoes magnetic resonance spectroscopy of the liver to assess liver density and choline compound mass. the patient then receives oral phosphatidylcholine supplement, and plasma and breast milk samples are taken at 3 and 6 hours after the dose. oral phosphatidylcholine supplements continue for 30 days. the above studies are repeated on day 31.

Eligibility criteria:
* patient with methionine adenosyltransferase deficiency who is nursing

Keywords: genetic diseases and dysmorphic syndromes inborn errors of metabolism methionine adenosyltransferase deficiency rare disease
combined dose-finding and cv outcomes study with csl300 (clazakizumab) in adult subjects with eskd undergoing dialysis

Conditions: Atherosclerotic Cardiovascular Disease; End Stage Kidney Disease; Atherosclerotic Cardiovascular Disease in Patients With ESKD

Summary: this is a 2-part (phase 2b/3) prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. part 1 (phase 2b) is a dose-finding study for csl300 vs placebo. part 2 (phase 3) aims to assess the efficacy of csl300 on cardiovascular (cv) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ascvd) or diabetes with end stage kidney disease (eskd) undergoing maintenance dialysis.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * a diagnosis of eskd undergoing maintenance dialysis for at least 12 weeks * serum hs-crp ≥ 2.0 mg/l * a diagnosis of diabetes mellitus or ascvd exclusion criteria: * subjects who participated in part 1 (phase 2b) are not eligible to participate in part 2 (phase 3) * concomitant use of systemic immunosuppressant drugs * abnormal lfts * any life-threatening disease expected to result in death within 12 months * a history of gi perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease * clinically significant active infection or history of opportunistic or invasive fungal infection

Keywords: end stage kidney disease (eskd) myocardial infarction (mi) atherosclerotic cardiovascular disease (ascvd) coronary artery disease peripheral artery disease diabetes
evaluation the treatment outcome for rfa in patients with bclc stage b hcc in comparison with tace

Conditions: Hepatocellular Carcinoma

Summary: evaluation the treatment outcome for rfa in patients with bclc stage b hcc in comparison with tace

the investigators conduct this clinical trial to evaluate the treatment outcome of rfa in hcc patients with tumor smaller than 7cm and tumor number less than five ,in comparison with tace treatment.the primary outcome is overall survival.the secondary outcome is objective response rate.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years ; * hcc confirmed by pathological or clinical diagnosis according to the american association for the study of liver diseases criteria ; * solitary hcc less than 7cm in diameter or multiple hcc lesions less 5 * the absence of portal/hepatic vein invasion, lymph node involvement and extrahepatic metastases; * lesions visible on ultrasound with a safe path between the lesion and skin; * an eastern cooperative oncology group performance status of 0-1; * child-pugh class a or b cirrhosis. the exclusion criteria : * received any other previous treatment for hcc; * severe coagulation disorders; * evidence of hepatic decompensation including hepatic encephalopathy, ascites as well as esophageal or gastric variceal bleeding; * presence of serious medical comorbidities, including serious dysfunction of the heart or kidney ; * currently had other malignancies in addition to hcc.
efficacy of ozone therapy and splint in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome (CTS)

Summary: this study will investigate the effectiveness of repeated ozone therapy combined with splint therapy for carpal tunnel syndrome (cts).cts patients will be split into two groups: ozone plus splint and splint only. both groups will use wrist splints for 3 weeks, with the ozone+splint group receiving weekly ozone injections for three weeks.


Eligibility criteria:
inclusion criteria: * being 18-65 years, with mil-modarete cts, symptoms continued for at least 3 months exclusion criteria: * hand edema or prior injections, thenar atrophy, prior cts surgery, severe emg results, recent physical therapy, steroids, or platelet-rich plasma for cts in the past year, and conditions causing secondary cts (e.g., thyroid disorders, diabetes, pregnancy, rheumatoid arthritis, dupuytren's contracture, inflammatory arthritis, connective tissue diseases). also excluded: neck or arm pain conditions (e.g., cervical disc herniation, wrist fracture, proximal upper extremity entrapment neuropathy, polyneuropathy, peripheral nerve damage, fibromyalgia), history of g6pd deficiency, uncontrolled hyperthyroidism, thrombocytopenia, and contraindications to general ozone therapy (e.g., ace inhibitors for severe cardiovascular instability).

Keywords: splint ozone therapy rehabilitation
assessment of accommodation behavior in children under myopia control treatment (pilot study)

Conditions: Accomodation; Biofeedback Training; Myopia

Summary: this study will examine the accommodative behavior in children undergoing myopia control treatments. a subset of children showing reduced accommodation, known to occur in while wearing multifocal soft contact lenses (mfcl) from previous studies, will undergo auditory biofeedback training to improve the accommodative response and possibly improve treatment efficacy. the results of this study will be used to design a larger clinical trial. aim 1 - the accommodation response in myopic children being treated with mfcl for six months or longer, will be determined. the accommodative response data will be collected while the patients are wearing the mfcl and will be compared to the baseline control response when the subjects wear single vision soft contact lenses (svcl). additional comparisons will include accommodative measures in untreated myopic children wearing spectacle corrections (unttreated controls), children being treated with ortho-keratology contact lenses, and children treated with low-dose atropine (0.01%, considered not to affect accommodation). how these additional myopia treatments affect the accommodation response has yet to be determined. aim 2 - children treated with mfcl who show reduced accommodative responses will undergo a brief period of auditory biofeedback accommodative training to determine whether the response in children can be improved and how long it can be sustained. improving the accommodative response in these patients may improve the treatment efficacy by increasing the effect of the positive power addition built into the lenses.


Eligibility criteria:
inclusion criteria: * best corrected monocular snellen visual acuity (va) ≧ 20/25 * age 8 - 15 years * refractive error spherical equivalent between -0.75 d and -10 d * astigmatism ≤ 0.75 d * age-appropriate amplitude of accommodation * no suspected or confirmed eye disease (anamnesis) * no accommodative or binocular function abnormalities * agreement to participate in the study (informed consent of parents, assent of child) * children who are currently under myopia control treatment should already be so for ≥ 6 months exclusion criteria: * persons who are incapable of giving consent * refractive error spherical equivalent \ -0.75 d * astigmatism \> 0.75 d * abnormal binocular functions * medication affecting accommodative response or causing dry eye
the panoptix trifocal iol: a study of patient satisfaction, visual disturbances, and uncorrected visual performance

Conditions: Cataract Surgery

Summary: prospective survey study of patients who previously underwent cataract surgery with the alcon panoptix or panoptix toric intraocular lens in both eyes.

this will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the alcon panoptix or panoptix toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral restor 3.0 implants.

Eligibility criteria:
inclusion criteria: * patients implanted with the panoptix or panoptix toric lenses bilaterally within 6 months of the survey administration. patients may have the toric version of this lens in neither eye, one eye, or both eyes. * patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures. * patients whose spherical equivalent outcome is within 0.5d of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters. exclusion criteria: * patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery. * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.) * patients with greater than grade 1 posterior capsule opacity. * patient sin the historical reference set who underwent astigmatic keratotomy or limbal relaxing incision during cataract surgery. -
phase i/ii study of recombinant human interferon-gamma (rifn-gamma) in hiv-infected children

Conditions: HIV Infections

Summary: primary: to determine the safety and toxicity of recombinant interferon gamma-1b ( rifn-gamma ) in hiv-infected children receiving ongoing zidovudine ( azt ) or didanosine ( ddi ) therapy. to document hiv-associated defects in neutrophil and/or monocyte function that are improved with rifn-gamma. secondary: to determine whether a change in cd4 cell count occurs and to assess virologic status and effects on azt and ddi pharmacokinetics. it is likely that infants and children severely immunocompromised by hiv infection would respond to immunomodulators that augment different portions of the host defense system. interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with hiv infection.

it is likely that infants and children severely immunocompromised by hiv infection would respond to immunomodulators that augment different portions of the host defense system. interferon-gamma has been shown to benefit children with severely compromised nonspecific immunity and may thus be of benefit to those with hiv infection. patients are treated with subcutaneous rifn-gamma 3 times a week for 24 weeks and are then followed for an additional 12 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: required: * azt or ddi therapy. * pcp prophylaxis. allowed: * antipyretics. * antiemetics. * antihistamines. * decongestants. * skin creams and lotions. * immunizations according to current recommendations. patients must have: * class p-2 symptomatic hiv infection. * ongoing azt or ddi therapy of 6 months or longer duration. exclusion criteria concurrent medication: excluded: * antiretroviral therapy other than azt or ddi. * chemotherapy for active malignancy. * amphotericin b for systemic fungal infections. patients with the following prior conditions are excluded: * history of congestive heart failure or arrhythmias. * history of congenital heart disease. * history of seizure disorder requiring anticonvulsant medication. (note: history of uncomplicated febrile seizures does not exclude.) prior medication: excluded within 8 weeks prior to study entry: * immunomodulators other than ivig. prior treatment: excluded: * red blood cell transfusion within 4 weeks prior to study entry. required: * ongoing azt or ddi therapy of 6 weeks or longer duration. * ongoing pcp prophylaxis for more than 6 weeks duration. ongoing alcohol or drug use.

Keywords: interferon-gamma, recombinant acquired immunodeficiency syndrome aids-related complex
a phase ⅲ clinical trial of recombinant covid-19 trivalent (xbb+ba.5+delta) protein vaccine (sf9 cell) in booster vaccination

Conditions: COVID-19

Summary: a phase ⅲ clinical trial of recombinant covid-19 trivalent (xbb+ba.5+delta) protein vaccine (sf9 cell) in booster vaccination to evaluate efficacy, safety and immunogenicity

a multicenter, randomized, double-blind, controlled, phase ⅲ clinical trial of recombinant covid-19 trivalent (xbb+ba.5+delta) protein vaccine (sf9 cell) in booster vaccination to evaluate efficacy, safety and immunogenicity in healthy population aged 18 years old and above

Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects. 2. basic or booster immunization with covid-19 vaccine ≥6 months. 3. ≥3 months of sars-cov-2 infection history, or never infected. 4. have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols. exclusion criteria: 1. axillary temperature ≥37.3℃. 2. sars-cov-2 antigen or nucleic acid screening positive within the last 48 hours. 3. anti-sars-cov-2 igm antibody was positive during the screening period. 4. it is in the advanced stage of malignant tumor and the disease control is unstable. 5. female pregnancy (pregnancy test results are positive), lactation period. 6. have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs. 7. have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions. 8. have been diagnosed with congenital or acquired immunodeficiency, hiv infection. 9. people who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past. 10. congenital or acquired angioedema/neuroedema. 11. asplenia or functional asplenia. 12. thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications). 13. received another investigational drug within 1 month prior to receiving the investigational vaccine. 14. received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month. 15. fertile female subjects did not use effective contraception within 1 month prior to enrollment. 16. fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization. 17. abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine. 18. medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.