Kornimate/medical-research-clean huggingface dataset:
articulation and phonology in children with unilateral cleft lip and palate

Conditions: Cleft Palate; Cleft Lip

Summary: the purpose of the study is to assess if there are any differences in the articulatory and phonological competence in pre-school children with unilateral cleft lip and palate (uclp) who are treated with different surgical methods of palatal repair.

a cleft palate may influence important functions such as eating, function of the ear/hearing, speech, occlusion, and in addition social skills and acceptability related to appearance. surgical treatment is aiming to minimize the impact of the cleft on these functions. nevertheless there is often a need of orthodontic treatment, and if the palate is involved, speech therapy and speech improving secondary surgery. the incidence of otitis media with effusion, and related hearing problems, is high among the children. the outcome is affected by type of cleft as well as surgical method, although not yet fully clarified. some consider the growth of the mid-face to be better if primary surgery of the hard palate is delayed, while speech development is considered to benefit from primary palate surgery performed as early as possible. yet we don´t know which surgical method is the best. in most parts of the world and at three of six treatment centers in sweden the palate is closed in one stage between 12 and 18 months of age. at the three other swedish centers the cleft in the soft palate is closed at 4-6 months, and the cleft in the hard palate is repaired at 2-3 years of age. video-recordings of the children at 3 and 5 years of age will be used for evaluation. the speech material at 3 years of age consists of spontaneous speech and word naming. at 5 years sentence repetition and a re-telling task is added. blindly transcription of the material after randomization, according to the transcription used for cleft palate speech in sweden based on the ipa and extipa conventions will be performed. about 30% of the material, randomly selected, will be re-transcribed and about 30% will be transcribed by an additional listener independently, for calculation of reliability. the results will be compared between groups regarding articulatory deviancies and phonological processes, and will be statistically analyzed. impact of ear problems, hearing and speech therapy will be assessed.

Eligibility criteria:
inclusion criteria: * born with unilateral cleft lip and palate * native swedish speaking exclusion criteria: * known syndromes and/or additional malformations

Keywords: unilateral cleft lip and palate primary palatal surgery articulation phonology one stage palatal repair two stage palatal repair
safety, pharmacokinetics, and efficacy study of nb-001 to treat recurrent herpes labialis

Conditions: Herpes Labialis

Summary: purpose of this study is to determine the safety and efficacy of topical applications of nb-001 as compared to placebo for the treatment of recurrent herpes labialis.


Eligibility criteria:
inclusion criteria: * 18 to 80 years of age of either gender * good general health * history of recurrent herpes labialis with at least 3 episodes per year exclusion criteria: * pregnant and/or nursing female * lesions or irritation on or around the lips that would interfere with recognition of a herpes labialis attack * treatment with topical steroids, antivirals, or new topical products on or around the lips in the week prior to the onset of an attack * known allergies to topical creams, ointments or medications. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cold sore
inhaled nitric oxide to prevent and treat bronchopulmonary dysplasia

Conditions: Pulmonary Disease

Summary: inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of bronchopulmonary dysplasia (bpd) or death 2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (nicu) all over the world. this multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (ino) in the treatment of the preterm infant with developing bronchopulmonary dysplasia. infants were followed until death or discharge to home. the trial will compare ino therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (cpap), surfactant and high frequency ventilation as adjuncts to ino therapy) as the control. during the initial dosing, ino was started at 5 ppm and could be decreased to 1-2 ppm. the infants would inhale no until weaned. infants will be monitored for signs of toxicity due to cumulated dosage of no and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.

Eligibility criteria:
inclusion criteria: * ga\<=34w,less than 7 days of age,oxygenation index (oi) of more than 10 after being ventilated for more than 48 hours or surfactant therapy * ga\<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days exclusion criteria: * lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm) * active pulmonary hemorrhage, unevaluated pneumothorax * preexisting bilateral grade 3-4 intraventricular hemorrhage * a platelet count \<100\*10\^9/l * an expected duration of ventilation of less than 48 hours

Keywords: preterm neonates bronchopulmonary dysplasia chronic lung disease inhaled nitric oxide respiratory therapy
safety and efficacy iodofiltic acid i 123 in the treatment of acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: this is an open-label phase 2 study recruiting low, moderate, and high likelihood acs patients from approximately 60 centers. patients will be imaged with iodofiltic acid i 123 for the detection of myocardial ischemia. readers independent of the clinical study centers will review results of imaging studies in a blinded fashion at an imaging core lab. the resulting independent reading of the images will be compared against the truth standard for acs.


Eligibility criteria:
inclusion criteria: * provide written informed consent and are willing to comply with protocol requirements * are 40 years of age or older. * are being evaluated for possible acs. * if female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control. exclusion criteria: * \<40 years of age. * females who are pregnant or lactating. * history of left ventricular ejection fraction (lvef)=40%. * history of mi. * acute st segment elevation on ecg. * left bundle branch block on ecg. * known history of significant allergy to x-ray contrast media or iodine/iodides. * currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (ranexa). * administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment. * underwent cardiac stress testing of any kind within 2 days prior to study enrollment. * serum creatinine level \>2.0 mg per dl. * received investigational compound and/or medical device within 30 days of admission into this study. * q-wave abnormalities consistent with previous mi
hepatitis c in renal transplant recipients

Conditions: Chronic Hepatitis C-virus Infection; Renal Transplantation

Summary: the aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine a induces changes in (i) hepatitis c-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis c-positive renal transplant recipients.


Eligibility criteria:
inclusion criteria: * written informed consent * prior renal transplantation * current tacrolimus-based immunosuppressive regimen * hepatitis c-infection * age 18-70 years exclusion criteria: * current hemodialysis or peritoneal dialysis * pregnancy or breastfeeding * known contraindication for cyclosporine a-treatment

Keywords: chronic hepatitis c-virus infection renal transplantation glucose tolerance immunosuppression
evaluation of knowledge about fever after consultation in the pediatric emergency department

Conditions: Febrile Illness; Fever; Stress

Summary: the purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit. single-center randomized controlled trial.

fever is a common symptom of viral or bacterial infection in pediatrics. previous studies using both qualitative and quantitative methods have established that intervention with parents/legal guardians on fever management decreases their worry and anxiety related to their child's occurrence of a febrile episode, limits unwise use of antipyretic medication (walsh, 2006; walsh, 2008; peetom, 2017), but also reduces the use of emergency room or telephone medical consultations (peetom, 2017). the majority of visits for febrile conditions in children over 3 months of age are avoidable and do not require emergency and/or hospital care. mistaken beliefs and lack of knowledge about what to do in the event of a febrile episode lead parents to consult a hospital emergency room for their child, which can have an impact on emergency room overcrowding. the proportion of emergency room visits for febrile conditions assessed by the intake and referral nurse (ior) as not requiring urgent care raises questions about parents'/legal guardians' knowledge of fever, its monitoring, and what to do during a febrile episode. the aim of our study is to evaluate parents' knowledge of fever and the appropriate course of action during a febrile episode in a pediatric emergency department of a parisian university hospital by comparing standard management practices with the knowledge provided by an information brochure.

Eligibility criteria:
inclusion criteria: * be of legal age * be the parent/legal guardian of a child aged between 3 months and 15 years, * a child with a fever \> 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age), * severity of care rating by the ioa grade 4 (non-emergency care) * parent affiliated to a social security system or entitled to it * parent under "ame" french social security system * parent informed and having signed the consent exclusion criteria * parent/legal guardian who does not speak or read french, * child with a pathology that does not allow for rectal temperature taking * parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure. * parent / legal guardian under guardianship

Keywords: febrile episode pediatric pediatric emergency department therapeutic education
safety and dose study of grn163l and velcade to treat patients with refractory or relapsed myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine safety and the maximum tolerated dose (mtd) of grn163l and velcade with and without decadron when administered to patients with refractory or relapsed multiple myeloma.

grn163l is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. inhibition of telomerase may result in antineoplastic effects.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease) * relapsed or refractory disease * ecog performance status 0-2 * adequate hepatic/renal function and platelet count * if previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction \> 50% * fully recovered from any previous cancer treatments and/or major surgery exclusion criteria: * prior allogeneic bone marrow transplant, including syngeneic transplant * bone marrow transplant within 12 weeks prior to study * known intracranial disease or epidural disease * inability to tolerate velcade * inability to tolerate decadron * prior malignancy (within the last 3 years) * clinically significant cardiovascular disease or condition * active or chronically recurrent bleeding (eg, active peptic ulcer disease * prolongation of pt or aptt \> the uln or fibrinogen \< the lln * clinically relevant active infection * serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease * any other cancer therapy within 4 weeks prior to study, with nitrosourea within 6 weeks prior to study * investigational therapy within 4 weeks prior to study * anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of iv access devices * radiation therapy within 4 weeks prior to study * major surgery within 4 weeks prior to study * active autoimmune disease requiring immunosuppressive therapy * known positive serology for hiv

Keywords: myeloma multiple myeloma relapsed multiple myeloma refractory multiple myeloma relapsed or refractory multiple myeloma
effects of sodium chloride or its substitute salt potassium chloride on vascular function

Conditions: Vascular Function; Healthy; Diabetes

Summary: this is a prospective, monocentric, randomized trial to investigate how sodium chloride or its substitute potassium chloride acutely affects vascular function by ingestion via a salted soup. furthermore we want to get insights on the pathophysiology by analyzing metabolism and cell function in relation to vascular reaction.

some of the leading death causes in western countries are attributed to artheriosclerosis with its consequences especially cardiovascular events. beside lifestyle risk factors such as physical inactivity, adipositas and stress, high dietary sodium intake is one of the easiest modifiable factors to reduce development and progession of artheriosclerosis. unfortunately high sodium diet is one of the hallmarks of western diet. epidemiologic and experimental data have provided compelling evidence that high salt and its induced elevation in bloodpressure is an important factor in the development and progression of cardiovascular disease, artheriosclerosis with its endorgan failure. to analyze the reasons for the hazardous effects of high oral sodium chloride exposure on vascular damage and a possible protective mechanism by the salt substitute potassium chloride, we intend to conduct a single-center randomized trial (escape-salt). we aim to measure vascular function by flow mediated dilation (fmd) and dynamic vessel analysis (dva) of retinal mircocirculation. participants will be divided into 3 groups. each group will be served a soup with different salt content. the salt composition is as follows: soup a (9 g sodium chloride), soup b (6 g sodium chloride plus 3 g potassium chloride), and soup c (6 g sodium chloride). the effects on blood pressure, body composition markers, electrolytes, inflammatory and metabolic response, and vascular function are measured before, 4 and 24 h after ingestion of the soup. furthermore we will investigate the underlying mechanism by performing metabolomic, transcriptomic and proteomic anyalysis.

Eligibility criteria:
inclusion criteria: * full-aged * signed informed consent * no dietary restrictions * access to retina for microvascular measurement exclusion criteria: * age \<18 y * no retinal access for microvascular measurement * known glaucoma * antibiotic therapy within the last 4 weeks * immunosuppressive therapie within the last 4 weeks (e.g. glucocorticoids) * s.p. malignancy * unknown fever within the last 4 weeks * salt wasting syndroms (e.g. renal tubular acidosis, diabetes insipidus) * chronic kidney disease stage 4-5 * known electrolyte disorder (e.g. hyperkalaemia, hypokalaemia, hypernatriaemia, hyponatriaema) * no or rejected informed consent

Keywords: potassium chloride sodium chloride microcirculation
24 months follow-up, two arm study to compare the cardiovascular profile in a regimen with everolimus + mycophenolic acid (mpa) versus (vs.) a regimen of cni+mpa in maintenance renal transplant recipients

Conditions: Renal Transplant

Summary: the objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients


Eligibility criteria:
inclusion criteria: * received kidney transplant \> 6 months and \< 3 years prior to study enrollment * receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid * between 18 and 70 years of age * willing to provide written informed consent exclusion criteria: * patients with an actual serum creatinine ≥ 2 mg/dl and/or egfr≤ 40 ml/min and/or proteinuria≥ 500mg/day * patients who suffered from severe humoral and/or cellular rejection (≥ banff iib, recurrent acute rejection or steroid resistant acute rejection in the previous years * patients who have severe hypercholesterolemia (\>350 mg/dl; \>9 mmol/l) or hypertriglyceridemia (\>500 mg/dl; \>8.5 mmol/l). patients with controlled hyperlipidemia are acceptable. * diabetic patients * woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception * presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements * any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study * receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment

Keywords: renal transplant, everolimus, cardiovascular profile, cni-free immunosuppression, left ventricular hypertrophy, biopsy proved acute rejection (bpar)
relationship of ochratoxin a to upper urologic cancers

Conditions: Transitional Cell Carcinoma; Renal Cell Cancer; Testicular Cancer

Summary: this pilot study will explore the relationship of ochratoxin a (ota) levels in patients with upper tract transitional cell (tcc), renal cell, and testicular cancers by measuring levels of ota in serum and tumor samples. dietary exposure will also be analyzed.

ochratoxin a (ota, a ubiquitous mycotoxin) is a common food contaminant that enters the food chain from plants such as cereals. ota can be inhaled or ingested and livestock and humans feeding on ota contaminated food have been found to have detectable levels of this chemical in their sera, liver, and kidneys. there is risk for occupational and environmental exposure to ota. thus, exposure to this mycotoxin may be a poorly recognized problem in our society. ota has been classified as a group 2b possible carcinogen. exposure to ota has been implicated in teratogenesis (fetal malformation), nephrotoxicity, gonadotoxicity and carcinogenesis. the mechanisms for these effects of ota have not been fully explained. there is an increasing incidence of testis cancer in western societies combined with the increasing ota exposures being reported. as well as studying the relationship of ota to tcc initially, we also plan to examine a possible relationship between ota and testicular cancer as well as renal cell carcinoma (rcc). to date, very little research into the effects of mycotoxins in humans has been performed. we plan to apply proven techniques of serum analysis using: 1. elisa or enzyme linked immuno-absorbent assay which is used to measure the presence of an antibody or antigen in the bloodstream 2. immunohistochemistry (pathological analysis from resected tumors) 3. high -pressure liquid chromatography (hplc) of tumor tissue to investigate the role of ota in human genitourinary cancers. a group of subjects without cancer will be used as a control group.

Eligibility criteria:
inclusion criteria: * study group 1. informed consent 2. must have resectable non-metastatic upper tract transitional cell carcinoma, renal cell carcinoma, or testicular carcinoma. 3. willingness to be followed for survival data. * control group 1. informed consent 2. no history of carcinoma exclusion criteria: 1. metastatic upper tract transitional cell carcinoma, renal cell carcinoma, or testicular carcinoma. 2. any other ongoing or previous malignancy other than basal or squamous cell skin cancer.

Keywords: upper tract transitional cell (tcc)
qingkailing injection versus puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the effect of qingkailing injection versus puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * with active ra * without taking any other medication for the treatment of active ra in at least 4 last weeks * aged from 18 to 75 years * without conflict to the written, informed consent signed prior to the enrollment. exclusion criteria: * being included in other clinical trial within the last 4 weeks * with abnormal liver or kidney function (more than 1 time above the high normal) * with serious cardiovascular disease * with hematologic disease * being in pregnancy, lactation period or under a pregnancy plan * with severe gastrointestinal disease * with contraindication or being allergic to the test drugs * being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs * being not compatible for the trial medication, or other circumstances at the discretion of investigators * without legal capacity or only with limited legal capacity.
enzalutamide treatment in covid-19

Conditions: COVID-19; Corona Virus Infection

Summary: covid-19 is a disease with high rate of morbidity if symptomatic. there is a great need of treatments to decrease the severity. the vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of tmprss2, necessary for virus internalization, or other mechanisms. enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as tmprss2. the aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of covid-19 patients.


Eligibility criteria:
inclusion criteria: * positive covid-19 test * mild to severe symptoms of covid-19 * hospitalization * who performance status 0-3 * age above or equal to 50 years * can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information. * estimated expected survival of 1 year (excluding symptoms due to covid-19) exclusion criteria: * severe allergy to enzalutamide * pregnant or breast-feeding women * need of immediate mechanical ventilation * current medication includes enzalutamide treatment * stroke or transitory ischemic attack in medical history * treatment for hiv * treatment with tamoxifen * treatment with immunosuppressive agents * severe immunosuppressive disease * treatment with warfarin or noac (non-vitamin k-antagonist anticoagulants) * previous seizure in medical history * other serious illness or medical condition * unstable cardiovascular disease

Keywords: enzalutamide randomized clinical trial covid-19 sars-cov2