Kornimate/medical-research-clean huggingface dataset:
ivacaftor impact in an adolescent without a cystic fibrosis-associated cftr (cystic fibrosis transmembrane conductance regulator) mutation for chronic pancreatitis: single-patient study tracking flare frequency and health data compared to historical records.

Conditions: Chronic Pancreatitis

Summary: the goal of this observational study is to learn about the long-term effects of ivacaftor in an adolescent without a cystic fibrosis-associated cftr mutation who is taking ivacaftor to treat chronic pancreatitis. the main question it aims to answer is: does ivacaftor reduce the frequency or severity of acute pancreatitis episodes in this adolescent compared to their historical medical data? the participant, who is already taking ivacaftor as part of their medical care, will be monitored over the course of 12 months. flare frequency, hospitalizations, and wellness data will be tracked through caregiver reports, lab data, and physiological data collected from a wearable health monitoring device (apple watch).


Eligibility criteria:
inclusion criteria: the subject has been diagnosed with recurrent acute pancreatitis or chronic pancreatitis and a clinical decision has been made to treat the subject with one or more fda-approved therapies, which may be being used off-label) to treat or prevent pancreatitis symptoms. exclusion criteria: participant has a known cystic fibrosis-associated cftr mutation that would qualify them for standard ivacaftor use. participant is unable to tolerate ivacaftor due to prior adverse reactions. participant has severe liver dysfunction or baseline liver enzyme elevations that contraindicate ivacaftor use, as determined by the treating physician. participant or parent/guardian is unwilling to comply with study procedures, including regular follow-up and data sharing. any other medical or psychological condition, in the judgment of the treating physician or counselor, that would make participation unsafe or not in the best interest of the participant.
left ventricular torsional hysteresis: a global parameter for diastolic function

Conditions: Heart Failure; Diastolic Heart Failure; Heart Failure With Normal Ejection Fraction

Summary: diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes abnormal lv diastolic distensibility, impaired filling and slow or delayed relaxation- regardless of whether the ejection fraction is normal or depressed and whether the patient is asymptomatic or symptomatic. epidemiologic studies have demonstrated high prevalence of diastolic heart failure (dhf). the quality of life of these patients is impaired and the clinical outcomes are similar to those with heart failure with systolic dysfunction. therefore diastolic dysfunction has significant adverse economic impact that is expected to grow further with time. clinical characteristics alone may not be sufficient to diagnose diastolic dysfunction. a number of invasive and non-invasive parameters have been proposed to diagnose diastolic dysfunction. most of the presently used non-invasive parameters have a number of limitations. high fidelity measurement of the left ventricular pressures is needed to accurately diagnose diastolic dysfunction. obtaining it in routine clinical practice is impractical. in this protocol the investigators have proposed a novel non-invasive parameter called 'torsional hysteresis' as a measure of diastolic function. this will be measured using non-invasive cardiac mri technique. during left ventricular contraction and relaxation, myocardium deforms. during cardiac cycle the myocardium goes back to baseline state prior to beginning of each contraction. however the rate with which it returns to the baseline state is variable. torsion indicates relative wringing motion of the ventricle around a left ventricular axis and is a global parameter of left ventricular deformation. the parameters have defined a new parameter called torsional hysteresis based on non invasive cardiac mri assessment. the parameters have hypothesized that for diastolic dysfunction, the torsional hysteresis area is increased as compared to no diastolic dysfunction group.


Eligibility criteria:
inclusion criteria: major inclusion criteria: normal screening lv ejection fraction. exclusion criteria: 1. atrial fibrillation or other significant cardiac arrhythmia on ecg 2. presence of pacemaker or defibrillator 3. angioplasty or primary coronary intervention pci/ptca during index cardiac catheterization. 4. patient is unable to undergo cardiac mri due to contraindication to mri (mri incompatible metal prosthesis or implants or significant claustrophobia). 5. patient taking phosphodiesterase 5 inhibitor (eg. sildenafil) will be excluded due to potential interaction with nitroglycerin.

Keywords: heart failure diastolic heart failure heart failure with normal ejection fraction
the effect of staining beverage on color alteration during in-office tooth bleaching

Conditions: Tooth Discoloration

Summary: this double-blind randomized controlled clinical trial aimed to investigate the effect of staining beverage on color alteration of in-office tooth bleaching procedures.

sixty-three eligible participants (25 males and 38 females, mean age 26.5 years) with at least one maxillary tooth demonstrating shade a3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different staining beverage used in this clinical trial: coffee for group c, tea for group t, and distilled water for group w. all participants will receive in-office tooth bleaching with 40% hydrogen peroxide (opalescence boost pf 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). the participants will be instructed to use only the provided beverage rinses for 30 seconds, four times daily. colour parameters (cie l\*, a\*, b\*) will be measured with a spectrophotometer (vita easyshade advance 4.0) at baseline (t1), after the first bleaching session (t2), after the second bleaching session (t3), 1 week after the completion of in-office bleaching (t4), and 3 weeks after the completion of in-office bleaching (t5). the colour differences (δe) and whiteness index (w) will also be calculated. the data will be statistically analysed through repeated anova and tukey's test (α = 0.05).

Eligibility criteria:
inclusion criteria: * patients between 18 and 30 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score a3 or darker, as measured with the vita classical guide (vita zahnfabrik, bad sa ̈ ckingen, germany) ordered by brightness exclusion criteria: * patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.

Keywords: tooth bleaching staining beverage
evaluation of the treatment approach robin

Conditions: Clinical High Risk for Psychosis

Summary: the prevention of schizophrenia and other psychotic disorders has led researchers to focus on early identification of individuals at clinical high risk (chr) for psychosis and to treat the at-risk symptoms in the pre-psychotic period. although at-risk symptoms such as attenuated hallucinations or delusions are common in adolescents and associated with a marked reduction in global functioning, the evidence base of effective interventions for adolescents at chr state and even ﬁrst-episode psychosis is limited. to fill this gap, the clinicians from the early intervention center in zurich have developed the treatment approach "robin" (standardized manual and smartphone app) for adolescents with high risk for developing a psychotic disorder. the treatment approach is based on existing therapy strategies for adolescents with first episode of psychosis and the available recommendations for adults with at-risk symptoms. the evaluation aims firstly to compare the efficacy of "robin" in 30 chr adolescents aged 14-18 to an active control group (treatment as usual) from a previous study. primary outcome measures will be at-risk symptomatology, comorbid diagnosis, functioning, self-efficacy and quality of life. for the prospective intervention condition (16 weekly individual sessions + a minimum 4 family sessions), help-seeking adolescents with chr for psychosis, aged 14-18, will be recruited over three years. at-risk and comorbid symptoms, functioning, self-efficacy and quality of life are monitored at six time points (baseline, during the treatment period, immediately after intervention, and 6, 12, and 24 months later) and compared to the respective measures of the active control group.


Eligibility criteria:
inclusion criteria: * 1) at least two self-experienced and self-reported cognitive basic symptoms as assessed by the children-youth version of the schizophrenia proneness interview child and youth version (spi-cy) * and/or 2) at least one attenuated psychotic symptom for psychosis assessed by the structured interview for prodromal syndromes (sips) exclusion criteria: * a diagnosis of a psychotic disorder * current substance or alcohol dependence * insufficient german or english language ability * low intellectual abilities with iq \<75
a multicenter registry of adalimumab in chinese adult patients with active ankylosing spondylitis

Conditions: Spondylitis, Ankylosing

Summary: a multicenter registry to explore the clinical outcome of chinese adult patients with active ankylosing spondylitis \*as\* treated with adalimumab,prescribed according to the local label,in the real world practice

this registry will be conducted in a non-interventional setting for as patients using adalimumab in china.the primary objective is to evaluate the effectiveness and safety of adalimumab in chinese as patients in real world clinical practice.the secondary objective is to 1)compare the clinical outcome in patients with or without good persistence with adalimumab;2)investigate the predicting factors of a good clinical response after discontinuation of adalimumab.

Eligibility criteria:
inclusion criteria: 1. adult patients with established diagnosis of ankylosing spondylitis. 2. patients eligible to use adalimumab according to the local label without any contraindication.(according to the local label, patients should be screened for active infection,tb,hbv,malignancy and chf before the prescription of adalimumab,patients with latent tb should start a full course of anti-tb therapy before the use of adalimumab.) exclusion criteria: 1.patients with contraindication or are not appropriate to use adalimumab according to the local label will be excluded

Keywords: spondylitis, ankylosing adalimumab prospective studies
chest shielding in premature infants during phototherapy

Conditions: Patent Ductus Arteriosus in Premature Infants

Summary: this is a feasibility study where infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. the primary outcome is patent ductus arteriosus.


Eligibility criteria:
inclusion criteria: * less or equal to 29 weeks or 1000g at birth * admitted to the nicu (neonatal intensive care unit) within 24 hours after birth * english speaking parents exclusion criteria: * congenital abnormalities * chromosomal disorders * cyanotic heart defects * nitric oxide * prophylactic phototherapy * unlikely to survive beyond 72 hours according to the attending neonatologist * do not require phototherapy

Keywords: pda jaundice phototherapy
serratus anterior plane block for improving pain and respiratory function in patients with multiple rib fractures

Conditions: Rib Fracture Multiple

Summary: this is an observational study which will evaluate the efficacy of the serratus anterior plane block for treating pain and respiratory capacity in patients with multiple rib fractures. when resources are available for a sapb to be performed, patients will receive this block in addition to traditional pain medications, while at other times, patients will receive traditional pain medications only.

pain management by systemic analgesics and by nerve blocks are both standard of care and used in emergency department (ed) depending on the resources available. not all ed physicians are trained or comfortable with the serratus anterior nerve block and thus it is not always available to patients and is provider dependent. this is an observational study where patients with multiple rib fractures will receive either a serratus anterior plane block (sapb) in addition to traditional forms of pain control when providers trained to perform the block are available, or will receive traditional forms pain control if trained personnel are not available. in addition to the serratus anterior plane block, standard forms of pain control in the stanford emergency department include: oral or parenteral acetaminophen, oral or parenteral nsaids, oral or parenteral opiates, parenteral lidocaine, and parenteral ketamine. retrospective evaluation of the allocation of patients to either nerve block or no nerve block will be dictated by physician ability, time and resources to do the block. the efficacy of the block will be evaluated by serial measurements of pain score and respiratory capacity.

Eligibility criteria:
inclusion criteria: 1. age greater or equal to 18 years of age 2. presentation to stanford university hospital emergency department within 12 hours of a traumatic incident 3. three or more anterior and/or lateral unilateral rib fractures diagnosed by ct 4. gcs 15, with the ability to discern and describe pain from rib fractures and give consent 5. presentation to the emergency department between 7am and 11pm (for identification by research assistants) exclusion criteria: 1. posterior rib fractures 2. bilateral rib fractures 3. sternal fracture 4. known allergy to local anesthetics 5. pregnancy 6. significant coagulopathy 7. hemodynamic instability
study to evaluate the efficacy and safety of ckd-352

Conditions: Dry Eye Disease

Summary: the purpose of this study is to compare the efficacy and safety of ckd-352 in patients with dry eye disease

active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of ckd-352 eye drops in patients with dry eye disease

Eligibility criteria:
inclusion criteria: 1. more than the age of 19 years old 2. subjects with dry eye symptoms for at least 3 month 3. subjects who sign on an informed consent form willingly exclusion criteria: 1. subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora 2. subjects who have clinically significant medical history of ocular disability 3. subjects who have malignant tumor within 5 years 4. subjects with known hypersensitivity to investigational product 5. women who are nursing, pregnant or planning pregnancy during the study 6. subjects who have received any other investigational product 7. impossible subjects who participate in clinical trial by investigator's decision

Keywords: dry eye disease ckd-352
effectiveness of an adapted physical activity program on improving the health-related quality of life of women with endometriosis in martinique

Conditions: Endometriosis

Summary: there is no specific treatment for endometriosis, because the pathophysiology is poorly understood. adapted physical activity (apa) is recognized as a beneficial supportive care for patients suffering from chronic pathology. adapted physical activity can play a role in managing endometriosis symptoms. studies have shown that regular physical exercise can help reduce pain, improve quality of life and alleviate symptoms related to chronic diseases. however, it is known that few women with endometriosis have regular physical activity because of pain, chronic fatigue that lead to activity limitation or even disability. this study provides an opportunity to evaluate the impact of regular apa practice on improving the quality of life and symptoms of women with endometriosis in martinique. based on this, apa could be included in the endometriosis care pathway in martinique.

the investigators' hypothesis is that apa improves the overall quality of life of women with endometriosis and also has a positive impact on pain, functional abilities and sleep. the effectiveness of the proposed adapted physical activity program also improves the psycho-social and professional impact of the disease in the daily lives of patients.

Eligibility criteria:
inclusion criteria: * adult woman of childbearing age, * clinico-radiological or clinico-histological diagnosis of endometriosis: laparoscopy with biopsy or mri, * history of endometriosis symptoms before diagnosis, * walking without technical assistance, * able to read and write, * patient wishing to improve her health by optimizing her lifestyle, * patient affiliated or beneficiary of a social security scheme, * patient having given free, informed and written consent. exclusion criteria: * acute or terminal illness, * recent fracture of the upper or lower limbs (\< 3 months), * other chronic unstable or orthopedic illness that could interfere with the ability to participate in a physical activity program, * resting ecg at inclusion outside the normal range, * patients who practice moderate to intense physical activity for more than 150 minutes per week, * absolute contraindication to physical activity linked to severe co-morbidities, * patient placed under legal protection, guardianship or curatorship, * pregnant or breastfeeding woman.

Keywords: endometriosis adapted physical activity quality of life
use of corifolitropin alfa in oocyte donors

Conditions: Female Reproductive Problem; Infertility

Summary: the purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant fsh or hp-hmg)

in recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. these improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging. simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. the need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established. corifollitropin alfa molecule is a full-length recombinant fsh generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily fsh preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.

Eligibility criteria:
inclusion criteria: * women aged 18-35 years who meet the entry criteria for the ivi donor program: * weight \< 60 kg * women with at least 6 antral follicles per ovary * women who will fit the protocoo during the period of the study * women who give written consent to participate in the test exclusion criteria: * women with basal antral follicle count above 20 or below 6. * women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.

Keywords: corifollitropin alfa, recombinant fsh, hp-hmg, apoptosis, oocyte donation
study on effective mydriasis in premature infants

Conditions: Retinopathy of Prematurity (ROP)

Summary: the purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for retinopathy of prematurity (rop).

premature infants need to have eye exams starting at about 4 weeks of age and continuing until their retinas (membrane at the back of the eye which collects and transfers light) is fully grown. these exams are done to see if they have developed rop, a disease which can lead to blindness if not treated. the ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of the eye) to see the retina. the drug that is used to dilate the pupil, cyclomydril, has been shown to have side effects in premature infants. no literature has shown what the optimal dose is for premature babies. nursery policy is to give 3 drops of cyclomydril in each eye, at 5 minute intervals, 45-60 minutes before a scheduled eye exam. we sought to reduce the dose without delaying the exam for an under-sized pupil. in the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2 drops of cyclomydril in the left eye and 3 drops in the right eye to serve as their own control. the zero-drop group was created to test the contralateral (opposite eye) effect of 3 drops in the right eye. pupil dilation size is measured using the colvard pupillometer by a pediatric ophthalmologist examiner (g.v.v.) who was not masked to study group assignment. measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes after the first drop was given. rop screening exam is done at the first opportunity to visualize the posterior and peripheral retina. additional drops are given at 120 minutes if the observer is unable to complete the exam prior to that point.

Eligibility criteria:
inclusion criteria: * premature infants undergoing clinically indicated retinal exams exclusion criteria: * ocular congenital anomalies * pre-threshold rop

Keywords: retinopathy of prematurity (rop) eye exams premature infants cyclomydril
study in subjects with small primary choroidal melanoma

Conditions: Uveal Melanoma; Ocular Melanoma; Choroidal Melanoma

Summary: the primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of light-activated au-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.

this is a phase 1b/2 open-label, ascending single and repeat dose clinical trial designed to evaluate the safety and efficacy of light-activated au-011 for the treatment of subjects with small primary choroidal melanoma. throughout the study, subjects will be monitored through medical and ophthalmic assessments. subjects will be followed for a total of 2 years.

Eligibility criteria:
inclusion criteria: * diagnosis of choroidal melanoma exclusion criteria: * have known contraindications or sensitivities to the study drug

Keywords: uveal melanoma eye cancer ocular melanoma choroidal melanoma