Kornimate/medical-research-clean huggingface dataset:
impact of propionic acid on regulatory t cell function in children with ckd

Conditions: CKD (Chronic Kidney Disease) Stage 5D

Summary: pro-kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. the investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in ckd patients treated with hemodialysis.

chronic inflammation is a major risk factor of cardiovascular disease progression in ckd, irrespective of confounding comorbidities. based on current knowledge, microbially-derived metabolites such as short chain fatty acids (scfa) play an important role in the regulation of chronic inflammatory processes in ckd patients. children with ckd are known to have reduced serum levels of the scfa propionic acid (pa), as a consequence of both gut microbial dysbiosis and reduced fiber intake. in animal and human studies the impact of pa on function and abundance of regulatory t cells (treg) has been demonstrated. consequently, the investigators aim to normalize the pa serum levels by oral pa food supplementation in hemodialysis patients in order to mitigate chronic inflammation.

Eligibility criteria:
inclusion criteria: * body weight: \> 30kg * ckd g5 treated with hemodialysis * continuous hemodialysis treatment for \> 3 months * clinical stable condition * manifestation of ckd within childhood (\<18 years) exclusion criteria: * disease or dysfunctions, which disqualifies the patient * incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study * acute infections * immunosuppressive therapy within the last 12 weeks before the start of the study * pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study * planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study * malignant diseases * pregnancy * chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease * alcohol- or drug abuse * parallel participation on other interventional trials
using of biomarkers and blood culture in early detection of systemic infections

Conditions: Invasive Fungal Infections

Summary: this work aims to: 1. validate the performance of crp, and pct in early differentiating ifi from bacterial bloodstream infections. 2. compare the results of crp and pct with the results of β-d- glucan. 3. find the relationship between biomarkers levels \[crp, pct and β-d- glucan\] and the results of blood culture which is the gold standard of diagnosis.

immunocompromised children with cancer receiving chemotherapy or undergoing hematopoietic stem cell transplant (hsct) are at high risk of infections. invasive fungal infection (ifi) is a significant cause of morbidity and mortality. the incidence of ifi from 5.3% to 24% and the mortality rate from 18.6% to 67.6%. definite diagnosis of fungal infection in immunocompromised patients is particularly challenging. however, the clinical presentation of ifi is not specific, especially in pediatric patients. the culture of blood is the major method to diagnose proven ifi, but the results are mostly negative, and culture is time consuming. new nonculture-based methods, including antigen-based assays, and molecular detection of fungal dna which may allow early diagnosis and treatment of fungal infection. molecular techniques, including dna sequencing and polymerase chain reaction (pcr). these techniques have become more available in many laboratories; however, it lacks methodological standardization, and the results vary widely among laboratories. more attention paid to the biomarkers. 1, 3- β -d- glucan (bdg) is a component of the fungal cell wall and therefore it considered a pan-fungal detection method. traditional biomarkers as c-reactive protein (crp) and procalcitonin (pct) have also been evaluated for their abilities in distinguishing ifi and other infections. in neonates, crp levels were significantly higher in fungemia than in bacteremia, in adult patients, there was not a significant difference between the candidemia and bacteremia groups. the pct value was markedly lower in the fungal infection group than in the bacteremia group at the onset of fever.

Eligibility criteria:
inclusion criteria: * patients clinically suspected to have invasive fungal infections such as fever, cough or retrosternal pain, oral mucositis or perianal pain. * drug history of corticosteroids or chemotherapy. exclusion criteria: * patients refuse to be part of the study. * patients have no symptoms of systemic infections. * drug history for antimicrobial before blood sample collection.
trial of pre-operative chemoradiotherapy followed by surgical resection in pancoast tumors (jcog 9806)

Conditions: Pulmonary Neoplasm

Summary: the purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

pre-operative radiotherapy has long been the community standard in pancoast, or superior sulcus tumor. however, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage iii non-small cell cancer. surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, swog reported favorable results of this trimodality approach in superior sulcus tumor. the current trial is a japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Eligibility criteria:
inclusion criteria: * newly diagnosed, pathologically documented non-small cell lung cancer (nsclc) * invasion to the first rib or more superior chest wall * age: 15-74 years old * eastern cooperative oncology group (ecog) performance status 0 or 1 * ample organ function * no prior chemo- or radiotherapy * signed informed consent exclusion criteria: * metastasis to, or involvement of, mediastinal node (n2) * distant metastasis or dissemination to pleura/pericardium * active concomitant malignancy * unstable angina, recent myocardial infarction, heart failure * uncontrolled diabetes or hypertension * pregnant or lactating women * other severe complications

Keywords: pulmonary neoplasm preoperative chemoradiotherapy surgical resection superior sulcus tumor chest wall invasion mytomicin c vindesine cisplatin
study of anlotinib in patients with differentiated thyroid cancer(alter01032)

Conditions: Differentiated Thyroid Cancer

Summary: the purpose of this study is to compare the effects and safety of anlotinib with placebo in patients with differentiated thyroid cancer.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent 2. histological documentation of differentiated thyroid cancer ,with measurable disease (using recist1.1) 3. ecog ps:0-1,life expectancy of more than 6 months 4. subjects must be 131i-refractory / resistant as defined by at least one of the following: * lesions that do not demonstrate iodine uptake on any radioiodine scan * cumulative activity of 131i of \>600 mci or 22 gigabequerels (gbq) * lesion that demonstrate iodine uptake on any radioiodine scan,but has progressed by recist 1.1 within 18 months of 131i therapy 5. main organs function is normal exclusion criteria: 1. prior treatment with anlotinib or vegfr-targeted therapies(such as vandetanib,cabozantinib,lenvatinib,sunitinib,sorafenib etc.) 2. subjects received radiotherapy external exposure or 131i within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study 3. patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer \[ ta (non-invasive carcinoma), tis (carcinoma in situ) and t1 (carcinoma invasion into lamina propria) \] 4. ctcae(4.0) grade 1 or higher non-remission toxicity induced by any other previous treatments，excluding alopecia and grade 2 or lower neurotoxicity induced by oxaliplatin 5. patients with factors that could affect oral medication (such as dysphagia etc.) 6. patients with pleural effusion or ascites, causing respiratory syndrome (ctcae grade 2 or higher dyspnea \[grade 2 dyspnea refers to shortness of breath with a small amount of activities, affecting instrumental activities of daily life\]) 7. patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
glanatec(r) for descemet stripping in fuch's endothelial dystrophy

Conditions: Fuchs' Endothelial Dystrophy

Summary: in brief, the objective of this study is to investigate whether the drug glanatec ® which is approved in japan for glaucoma and ocular hypertension, can be used in patients with fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. while some limited data exists as a proof of concept in in vitro or animal studies, and glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety. the goal of the study is to provide sufficient proof of concept for the use of this drug in patients with fed whose only treatment alternative is to undergo corneal transplant.


Eligibility criteria:
inclusion criteria: * • ability to understand read and sign the informed consent form. * age between 30 and \<91 years * ability to understand and follow instructions and study procedures * willingness to comply with all study procedures and be available for the duration of the study * ability to apply eye drop medication and willing to adhere to study medication regimen * diagnosed with fuchs dystrophy (clinically and on confocal microscopy) by the study investigator. * pseudophakic fed with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens. * fuchs dystrophy grades 2-4 on the krachmer grading scale * presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema * clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy * best corrected visual acuity in the study eye is 20/40 or worse at study enrollment * the patient is dissatisfied with current vision * the patient is otherwise to be offered a corneal graft * for females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence). * indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation exclusion criteria: * • uncontrolled glaucoma (iop \>25 mmhg) * presence of secondary corneal pathology such as infective or autoimmune keratitis * advanced corneal stromal edema defined as the presence of haze, bullae, or dm folds on slit-lamp biomicroscopy * history of herpes simplex virus or cytomegalovirus keratitis * prior endothelial keratoplasty * aphakic in study eye. * allergy to any component of the ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study * for women of child-bearing potential: pregnant or lactating, or planning to become pregnant within the next 6 months. * any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.
acidity level of blood from primary molar's pulp while undergoing pulpotomy or pulpectomy procedure

Conditions: Healthy

Summary: the aim of this study is to evaluate the level of acidity of blood samples that are been taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. our hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples from teeth undergoing pulpotomy would bo neutral.

the samples will be collected by 1 m"l syringe that is pre-washed with heparin.than the samples will be analyzed in an astrop machine of neonates.

Eligibility criteria:
inclusion criteria: * no systemic disease * teeth that are undergoing pulpotomy or pulpectomy exclusion criteria: * systemic disease * pulp necrosis * permanent teeth

Keywords: samples children the age group 3-13 years
abdominal circumference measure in caesarian section

Conditions: Anesthesia, Spinal; Cesarean Section

Summary: the goal of this observational study is to evaluate preoperative measures of abdominal circumference in patients admitted for a cesarean section. the main questions it aims to answer are: * can preoperative abdominal circumference predict patients with difficult spinal anesthesia * can preoperative abdominal circumference predict the occurrence of maternal hypotension during cesarean section participants will be examined preoperatively in terms of visibility and palpation of spinous processes, abdominal circumference will be measured in the supine and sitting positions with other clinical parameters. spinal anesthesia will be performed by the same experienced anesthesiologist with a standardized procedure. the number of skin punctures, needle reorientations, traumatic cerebrospinal fluid, need for a paramedian approach or failure will be recorded. maternal blood pressure and vasopressor requirements will also be monitored.


Eligibility criteria:
inclusion criteria: * parturients admitted for elective or emergency cesarean section exclusion criteria: * acute fetal distress * umbilical cord prolapse * scoliosis * contraindication to spinal anesthesia * medical history of spinal surgery american society of anesthesia status 4 or 5

Keywords: preoperative evaluation abdominal circumference difficult spinal anesthesia maternal hypotension cesarean section
the phosphodiesterase 3 inhibitor cilostazol as an adjunct to conventional therapy in patients with osteoarthritis

Conditions: Osteoarthritis

Summary: cilostazol is able to suppress the degradation of type ii collagen in human chondrocytes induced by il-1b. cilostazol add-on for celecoxib therapy has synergistic anti-arthritic potential by inhibiting proinflammatory cytokine production in synovial fibroblasts through the il-10/socs3 pathways, consequently leading to the inhibition of synovial cell proliferation and overcoming the perpetuation of synovial inflammation.


Eligibility criteria:
inclusion criteria: * primary osteoarthritis patients recruited were between 30 to 60 years of age, with x-ray confirmed kellgren-lawrence grade13 ii or iii severity primary tibiofemoral oa, according to the american college of rheumatology criteria. exclusion criteria: * those patients were excluded from the present study who: * were of age less than 30 years or more than 60 years * presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug * were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying oa of the hip of sufficient severity to interfere with the functional assessment of the knee * had previous or ongoing treatment with oral sysdoa (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study * were having a known hypersensitivity to the used medications * have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%). * patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
osteopathic medicine in fibromyalgia syndrome

Conditions: Fibromyalgia Syndrome

Summary: the purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.

an osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia. this technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension. this is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. the purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. it includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months. the primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (eva). the secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations. this study will also allow to identify the profile of the osteopathic treatment responders patients

Eligibility criteria:
inclusion criteria: 1. patient male or female aged at least of 18 2. patient with fibromyalgia, according to the american college of rheumatology (acr) 1990 criteria, with a global level of pain of 50 over a 100 mm eva scale 3. patient suffering from fibromyalgia for over a year 4. patient with stable medical/non medical treatment for at least 1 month before the recruitment 5. patient referred to a medical center for a multidisciplinary approach 6. patient who can be followed for at least 12 months after the end of the osteopathic sessions 7. patient giving his informed consent to participate in the study 8. patient affiliated to or beneficiary of social insurance exclusion criteria: 1. treatment by physical approach in progress or not older than 3 months : physiotherapy, kinesitherapy, rehabilitation or manual treatment (osteopathic or chiropractic care, manual medicine) 2. unability to attend 6 sessions, meaning one weekly session, of osteopathy, at hôtel dieu 3. severe psychiatric pathology : major depression, psychosis 4. pregnancy or breast feeding 5. the patient is already included in another clinical study 6. patient under judicial protection

Keywords: fibromyalgia syndrome pain quality of life osteopathic treatment
inhaled nitric oxide by oxygen hood in neonates

Conditions: Respiratory Failure; Infant; Persistent Fetal Circulation

Summary: inhaled nitric oxide (ino) improves oxygenation in term infants with respiratory failure. however, ino has been primarily used in infants receiving mechanical ventilation. this study is a pilot study to determine if ino given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.

inhaled nitric oxide (ino) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. we have shown that ino administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group b streptococcus-induced pulmonary hypertension in an animal model (j perinatol 2002; 22:50-6). our objective was to determine the feasibility of ino administration by oxygen hood in neonates with respiratory failure. methods: a masked randomized controlled trial was performed on eight infants with respiratory failure. inclusion criteria were: gestation\>34 weeks, age\ 100 mm hg, while oxygenation was unchanged in the controls. methemoglobinemia and other adverse effects were not noted in any infant. environmental levels of no and no2 were minimal (\ 0.3m from the hood. conclusions: administration of ino by oxygen hood is feasible. larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.

Eligibility criteria:
inclusion criteria: * gestation \>34 weeks at birth * age \<7 days * post-ductal arterial line * an a-ado2 of 400 to 600 on two blood gases, at least 30 minutes apart. exclusion criteria: * infants with major malformations * infants with cardiac disease

Keywords: hypoxia respiratory failure infant, term nitric oxide
i select - irbesartan in hypertensive patients with left ventricular hypertrophy

Conditions: Hypertension

Summary: * to evaluate blood pressure (bp) reduction to the targeted values (bp ≤ 140/90 mm hg in non-diabetic patients, and ≤ 130/80 mm hg in diabetic patients). * to emphasize and to evaluate the benefit of irbesartan in the reduction of left ventricular mass index in hypertensive patients with left ventricular hypertrophy. * to demonstrate safety of irbesartan in this population.


Eligibility criteria:
inclusion criteria: * patients with proven mild to moderate hypertension. * patients must have left ventricular mass index \> 130g/m2 in men, \> 100g/m2 in women, as evidenced by echocardiography before inclusion. * newly diagnosed "naïve" hypertensive patients (no prior treatment for hypertension). or, * patients who were receiving antihypertensive agents (maximum two agents including one diuretic) with blood pressure targets achieved, yet, in the investigator's opinion, those patients would benefit more from switching to the study medication. these patients will undergo a wash out period for not less than 7 days prior to enrollment. exclusion criteria: * severe hypertension (systolic bp ≥ 180 mm hg or diastolic bp ≥ 110 mm hg). * patients with left ventricular ejection fraction \< 45%. * patients with severe left ventricular hypertrophy. * patients with known secondary hypertension (for another cause other than type 2 diabetes mellitus). * diabetic patients with hba1c \> 10%. * significant chronic renal impairment (serum creatinine \> 2.0 mg/dl). * significant liver disease as shown by sgpt/sgot (alt/ast) \> 2.5 times the upper limit of the normal range. * currently pregnant or lactating females. * women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. * any patient who is in need for a combination antihypertensive therapy from the start (from the medical point of view of his/her physician). * known hypersensitivity to irbesartan, other arbs(angiotensin receptor blockers), hydrochlorothiazide, or other thiazide diuretics. * patients with malignancy during the past 5 years, known collagen disease or severe cardiac, cerebrovascular or gastric disease. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.