Kornimate/medical-research-clean huggingface dataset:
double-masked trial of nova22007 (1mg/ml ciclosporin/cyclosporine) versus vehicle in pediatric patients with active severe vernal keratoconjunctivitis

Conditions: Vernal Keratoconjunctivitis

Summary: the objective of this study is to compare the efficacy of two different dosing regimen of nova22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.


Eligibility criteria:
inclusion criteria: * males or females from 4 to less than 18 years of age. * history of at least one recurrence of vernal keratoconjunctivitis (vkc) in the past year prior to enrolment. * patients not receiving any treatment for an established and active vkc; or patients already receiving treatment for their vkc provided treatment is stopped according to the wash-out period specified in the exclusion criteria. * active severe vkc consistent with grade 3 or 4 of bonini scale (bonini 2007) with severe keratitis (grade 4 or 5 on the modified oxford scale). * mean score of 4 subjective symptoms (photophobia, tearing, itching and mucous discharge) ≥ 60 mm using a 100 mm visual analogue scale (where "0" means no symptom and "100" means the worst that have been ever experienced). exclusion criteria: * any relevant ocular anomaly other than vkc interfering with the ocular surface including trauma, post radiation keratitis, severe blepharitis, rosacea, corneal ulcer etc. * abnormal lid anatomy, abnormalities of the nasolacrimal drainage system or blinking function in either eye. * active herpes keratitis or history of ocular herpes. * active ocular infection (viral, bacterial, fungal, protozoal). * any ocular diseases other than vkc requiring topical ocular treatment during the course of the study. * contact lenses wear during the study. * topical and/or systemic use of corticosteroids within one week prior to enrolment. * topical ciclosporin (e.g. restasis®), tacrolimus or sirolimus within 90 days prior to enrolment. * scraping of the vernal plaque within one month prior to the baseline visit. * ocular surgery within 6 months prior to the baseline visit (excluding surgical treatment of the vernal plaque). * disease not stabilized within 30 days before the baseline visit (e.g., diabetes with glycemia out of range, thyroid malfunction, uncontrolled autoimmune disease, current systemic infections) or judged by the investigator to be incompatible with the study. * presence or history of severe systemic allergy. * any systemic immunosuppressant drugs within 90 days before the baseline visit. * known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein, etc). * history of malignancy in the last 5 years. * pregnancy or lactation at the baseline visit. * history of ocular varicella-zoster or vaccinia virus infection.

Keywords: vernal keratoconjunctivitis ciclosporin cyclosporine
laparoscopic reduction of intussusception in children: role in primary reduction after failed non-surgical therapies

Conditions: Intussusception

Summary: laparoscopic reduction of intussusception in children: role in primary reduction after failed non-surgical therapies.

intussusception is one of the main abdominal emergencies in children. its diagnosis is usually based on the clinical features and confirmed either by u/s and /or barium enema and ct scan in rare occasion. since the introduction of the hydrostatic reduction of intussusceptions by ravitch in 1848, it became the gold standard management. however surgical intervention is required if this and other non-operative approaches fail. this typically involves 10 to 20% of cases. early on, the approach has been through an open laparotomy and manual reduction of intussusception. later, the introduction of the laparoscopy in the paediatric surgical field has added another dimension to the management of intussusception. in addition to its confirmed general benefits of less pain, better cosmoses, and low long-term risk of adhesive bowel obstruction, it also can be a diagnostic modality in certain cases, primary reduce the intussusception and in some cases to resect the pathological lead point or the damaged segment of bowel. the laparoscope allowed the surgeons to avoid unnecessary open procedures in cases of spontaneous reduction following enema reductions, obviating the need for an open procedure in up to 30% of cases. despite of all mentioned above, its effectiveness has been questioned.

Eligibility criteria:
inclusion criteria: * 1. childs aged 1 year to 12 years with intussusception who failed the hydrostatic reduction. exclusion criteria: - 1. childs with bad general conditions ( coagulopathy, haemodynamic instability, and severe cardiopulmonary diseases). 2. known primary disease e.g. lymphoma and major congenital anomalies. 3. previous abdominal surgeries.
transition from adolescents to adulthood for patients with congenital heart diseases

Conditions: Congenital Heart Diseases

Summary: the investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

the number of adults with congenital heart diseases (chd) is increasing. however, many young adults are lost to follow-up even in experienced tertiary care centers. american and european guidelines recommend to improve the management of young adults with chd. structured therapeutic education programs are therefore needed to optimize the transfer to adult healthcare. our tertiary care chd center recently implemented a transition program and simultaneously investigators decided to measure its impact. indeed investigators need data from randomized trials in this filed. after previous controlled quality of life studies among children and adults with chd, investigators chose to use the health-related quality of life (hr-qol) as primary endpoint in this randomized study to focus on patient related outcomes. the investigators assume that patients who participate in this program will improve their quality of life compared to controls. if investigators demonstrate the benefit of this program, it will have important consequences for patients with chd and eventually for patients with other chronic medical conditions.

Eligibility criteria:
inclusion criteria: * patient from 13 years to 25 years inclusive. * carrying of congenital heart disease as defined in the international classification. * possible follow-up for one year on one of the three hospital center. * informed consent of the patient for adults and, parents or legal guardians for minors. * affiliation to a social security system. exclusion criteria: * non-francophone, * severe intellectual impairment.
dti & tractography in pediatric tumor surgery

Conditions: Brain Damage, Chronic; Cerebellar Cognitive Affective Syndrome; Cerebellar Mutism

Summary: the goal of this project will be to demonstrate that synaptive medical's diffusion tensor imaging(dti) product functionality used in pre-operative planning and intraoperative surgical navigation, improves clinical outcomes corresponding to a reduction in neurological and neuropsychological deficits in pediatric brain tumor surgery.

brain tumours are the most common form of solid tumours in children which often arise from the cerebellum. treatment involves a complete resection of the tumour. although surgical resection may eliminate most of the malignancy, signs of post-neurologic deficit may present as a consequence to the treatment. one such example is cerebellar mutism syndrome (cms), a postoperative syndrome typically arising 1 to 2 days after resection of a midline posterior fossa tumor; it consists of diminished speech progressing to mutism, emotional lability, hypotonia, and ataxia. while some of the symptoms recover after a few months, neuropsychological testing shows long term deficits in language (agramatism), executive function and verbal memory. this study aims to investigate whether the use of synaptive medical's brightmatter™ technology can help neurosurgeons better visualize and plan surgeries by avoiding eloquent fiber tracts in the brain and cerebellum; thus minimizing damage pertaining to neurologic and motor functionality. the use of these products will also be assessed for improved clinical outcomes in pediatric tumor surgery.

Eligibility criteria:
inclusion criteria: * pediatric subjects between the ages of 0-18 years with a brain tumor. exclusion criteria: * pediatric subjects with contra-indication to mri (metal, claustrophobia, etc.)
reha drive: capacitive electrocardiography in car seat in cardiological patients

Conditions: Cardiac Events

Summary: in this trial contactless heart rate, electrocardiography and breathing rate measurements are elevated during car simulation in cardiac rehabilitation via automotive sensors and camera.

increasing number of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to their fitness of driving during cardiac rehabilitation. little trial data are known, only a position paper of the german cardiac society (dgk) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience. for judgement and recommendations automotive monitoring via contactless sensors might be helpful. therefore while "driving" in a simulator distinct heart circulation situations will be created. vital signs will be measured via long term electrocardiography (ecg) in comparison to contactless capacitive ecg (cecg) measurements via embedded sensors in the car seat as well as heart rate and breathing rate measurements via camera.

Eligibility criteria:
inclusion criteria: * cardiologic diseases after acute event (e. g. myocard infarction, bypass surgery) * rehabilitation in clinic "an der rosenquelle" exclusion criteria: * dementia * lack of language ability * pregnancy * implanted electric devices (as e.g. heart pacemaker, inverted cardiodefibrillator)

Keywords: capacitive electrocardiography eulerian magnification method
glycated hemoglobin targets and glycemic control in indonesian diabetic patients

Conditions: Diabetes Mellitus

Summary: this study aims to compare uric acid, lipid, and kidney profile along with management and complications of indonesian diabetic patients with good and poor glycemic control based on glycated hemoglobin profile.

adult patients (≥ 18 years of age) with type 2 diabetes which are diagnosed under icd-10 coding of e-11 were included in this study. the inclusion criteria are patients with primary diagnosis of e11and have visited the clinic at least twice with a complete record of glucose, uric acid, lipid and kidney profile. participants were grouped into 2 groups - good and poor glycemic control based on their glycated hemoglobin (hba1c) levels. good glycemic control is defined according to the american diabetes association and the indonesian association of endocrinologists (perkeni) cut off of hba1c \< 7.0. data such as age, sex, ethnic, education, bmi, glucose, uric acid, lipid, and kidney profile as well as comorbidities and type of drug used were collected from the patients' medical records. comorbid conditions were defined as either concomitant hypertension, dyslipidemia, chronic kidney disease, hyperuricemia, or combinations of them as diagnosed in the medical records. diabetic complications of interest include macrovascular (heart disease, stroke), microvascular (nephropathy, retinopathy, neuropathy) and a combination of both as well as infection (urinary tract infection, pneumonia). these complications were also based on the medical records. management modalities included were lifestyle modification, use of oral antidiabetic medications or insulin, or both.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * must have visited the clinic at least twice, one before and one post-therapy exclusion criteria: * type 1 diabetes, gestational diabetes and other secondary diabetes types * unavailability of hba1c results - pre and post-therapy * incomplete records of glucose, uric acid, lipid and kidney profile, comorbidities and management.

Keywords: diabetes mellitus glycemic control lipid profile kidney profile uric acid
remicade safety line (study p03236)(completed)

Conditions: Arthritis, Rheumatoid

Summary: the goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

this study used a non-probability sampling method.

Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis confirmed with adequate clinical response(acr) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab. exclusion criteria: * as per summary of product characteristics (smpc)
low-dose methotrexate for change in global initiative for asthma step 5 medications in chronic severe asthma

Conditions: Low Dose Methotrexate in Severe Chronic Asthma

Summary: patients with chronic severe asthma (csa) have a crippling disease and current available treatments are not satisfactory. thus, management of csa remains a major unmet need. although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks, findings with low-dose methotrexate (mtx) are encouraging. however, larger and well designed clinical trials are required to establish the beneficial role of mtx in csa and for the detection of the key characteristics of those who are going to respond to this drug. this study will be the first multi-centre rct investigating the role of an add-on immunological modifier as a clinically useful therapeutic strategy in patients with well-phenotyped chronic severe asthma. as such, this study does not overlap with any other research currently ongoing.

patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers. all patients will meet the stringent diagnostic criteria for csa, including the requirement for the regular use of step 5 medications (i.e. oral prednisone and/or omalizumab). the experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits including run-in and run-out periods. patients will be randomly allocated to receive either mtx or matched placebo once a week as add-on therapy to their existing medication after run-in. physiological, laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments. we expect that mtx will reduce step 5 medications dosage in patients with csa without compromising the overall disease control. improvement in several indicators of asthma severity and control will be also investigated

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of csa taking gina step 5 medications (i.e. regular ocs and/or omalizumab for a minimum of 6 months); 2. failure in weaning patients completely from step 5 medications during run-in; 3. male and female individuals age 18 - 75 years; 4. patients must be able to provide consent; exclusion criteria: 1. use of immunomodulatory therapies in the preceding 3 months; 2. recent or current history of alcoholism; 3. high liver enzyme levels (greater than 2.5 times the upper limit of the normal range); 4. serum creatinine levels greater than 2.0 mg/dl 5. acute illness within 15 days of study medication administration; 6. leucopenia (below 3.0x109/l) and/or thrombocytopenia (below 100x109/l). 7. pregnancy or planning to become pregnant;

Keywords: chronic severe asthma, immunomodulation, methotrexate, steroids, omalizumab
a study to investigate bay2402234, a dihydroorotate dehydrogenase (dhodh) inhibitor, in myeloid malignancies

Conditions: Leukemia

Summary: the primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (mtd), or pharmacological active dose (pad) of bay2402234 in patients with acute myeloid leukemia (aml), myelodysplastic syndrome (mds), or chronic myelomonocytic leukemia (cmml). the secondary objective is to evaluate evidence of clinical efficacy associated with bay2402234 in patients with aml (defined as complete remission, complete remission with partial hematologic recovery), and mds (defined as hematological improvement).


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory aml. relapsed aml is defined as relapse after achieving a response to initial therapy and refractory aml is defined as failure to achieve a response after one previous line of therapy. response is defined as per iwg criteria (cr, cri or crp). patients who are not candidates to receive or who decline standard of care therapy are also eligible. * patients with intermediate-1 or higher risk mds who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion. * patients with relapsed/refractory cmml. * estimated glomerular filtration rate (egfr) \> 40 ml per 1.73 m\^2 * patients must have adequate coagulation (international normalized ratio \[inr\] ≤ 1.5; activated partial thromboplastin time \[aptt\] ≤1.5 x the upper limit of normal \[uln\]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion) * adequate liver function (total bilirubin ≤1.5 x uln (or ≤3 x uln in patients with documented gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase \[alt\] and aspartate aminotransferase \[ast\] ≤3 x uln (or ≤5 x uln for patients with liver involvement of their myeloid disease) exclusion criteria: * patients eligible for hematopoietic stem cell transplantation * clinical symptoms suggesting active central nervous system (cns) leukemia or known cns leukemia * human immunodeficiency virus (hiv) infection * chronic or active hepatitis b or c if not controlled by antiviral therapy * history of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug * serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. prophylactic antibiotic, antifungal and/or antiviral therapy is permitted * left ventricular ejection fraction (lvef) \<40%

Keywords: acute myeloid leukemia myelodysplastic syndromes chronic myelomonocytic leukemia dihydroorotate dehydrogenase (dhodh) inhibitor
circadian intervention to improve cardiometabolic health

Conditions: Cardiometabolic Syndrome; Type 2 Diabetes; Sleep; Time Restricted Feeding; Lifestyle Factors; Overweight and Obesity; Insulin Sensitivity; Eating Habit; Sleep Hygiene

Summary: the overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (hssd). participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. the circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

the study is a randomized controlled trial with control and circadian intervention groups. group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. the circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for \~8 weeks. both groups will have equal contact time with the study team. prior to enrollment participants will complete an clinical overnight sleep disorders screening. baseline consists of an \~1-week ambulatory real-world monitoring segment. following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. at the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.

Eligibility criteria:
inclusion criteria: 1. age: 18-45 years old; equal numbers of men and women 2. body mass index (bmi): 25.0-34.9 kg/m2, 3. sleep habits: habitual self-reported average total sleep time (tst) \<6.5 hours per night for prior 6 months exclusion criteria: 1. clinically diagnosed sleep disorder or major psychiatric illness 2. evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease) 3. use of prescription drugs or substances known to influence sleep or glucose metabolism 4. shift-work: current or history of within last year 5. weight change: \>10% of body weight over prior six months 6. experiencing menopause or post-menopausal 7. current enrollment in weight loss or physical activity program like the diabetes prevention program 8. currently pregnant or planning to become pregnant, or currently lactating. 9. currently smoking 10. alcohol intake \>3 drinks per day or \>14 drinks per week
effect of hypertonic solutions on allergic rhinitis patients

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to assess the effectivity of using hypertonic nasal solutions alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients, retrospectively.

the medical records of the patients who admitted to outpatient clinic of otorhinolaryngology department of a tertiary referral center were retrospectively investigated. the symptom scores and nasal eosinophil levels of the patients were recorded. patients using hypertonic solutions alone or steroid nasal spray alone were compared.

Eligibility criteria:
inclusion criteria: * patients with positive prick's test to at least one allergen and diagnosed as having allergic rhinitis were included * patients who used hypertonic nasal solution alone for at least one month were included as sthe study group * patients who used nasal steroid spray alone or at least one month were included as sthe study group exclusion criteria: * patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, copd and other systemic diseases were excluded

Keywords: allergic rhinitis nasal steroid hypertonic saline eosinophil symptom score