cyrilzakka/clinical-trials huggingface dataset:
Effects of Early Short-term Intravenous Iron Supplements Combined EPO in Preterm Infants

There are wide variations in iron supplementation practices in NICU.Guidelines on pediatric Parenteral nutrition suggested the dose of 200μg/kg.d iron by parenteral nutrition.

The study was approved by the ethics committee of Xinhua Hospital, and all parents gave written informed consent.

Study Design This was a randomized, controlled, double-blind, interventional trial of iron (iron sucrose) supplementation given from age of 1 day until full 2 weeks to preterm infants in NICU, who divided into three groups, control(PN without iron and EPO), Vifor and vifor and EPOE group, according to the recommended dosage of ESPEN .

Outcome Measures General information and indicators including anemia iron storage were measured. And the same time oxidative stress indicators were monitored at age of 1day and 2 weeks.

General growth parameters including the blood sugar, liver and renal function index before and after the intervention were tested.

Hematological evaluation including RBC, Hb, MCV, MCH, MCHC, RET, CRP were mesured before and after the intervention. The three groups were all peripheral blood.

Iron storage evaluation including ferritin, serum iron, TIBC on the days were measured before and after the intervention. We used the radio-immunoassay method to test the ferritin (DADE BEHRING, Germany), the chemical method to the serum iron and the automatic biochemical analyzer (automatic biochemical analyzer, 7600, HITACH).

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with birth weight less than 2.5kg Have parenteral nutrition indication With written informed consent of parents or guardian

Exclusion Criteria:

* Kidney and liver function abnormal have hemolytic disease have hemorrhagic disease have Serious congenital malformation have septicemia have plethora newborn use TPN less than ten days
A Study of High-Risk Oral Cavity Cancer

Objectives:

1. To study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment.
2. To study the toxicity and compliance of post-operative anti-angiogenesis therapy

Study design:

This is a multi-center randomized controlled phase II/III two-stage study.

Study endpoints:

The primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups.

Type and number of patients:

Patients with resectable oral cancer of clinical stage N2, 3 or skin-involved T4 will be enrolled.

Sample size at the first stage is 64 patients per group and the total sample size at the end of the second stage is 192 patients per group, assuming that the accrual rate/hazard rate = 1.33, an α=0.05 and power of 0.8 (Hypotheses: H0:θ ≦ 1.0 and Ha: θ ≧ 1.33)

Treatment schedule:

Group A：standard postoperative concurrent chemoradiotherapy.

Group B：Immediately after operation starts thalidomide (50) 4# per day and celecoxib (200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy.

Group C：Immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue).
2. Clinical stage T4a with skin involvement or resectable N2-3 by UICC/AJCC 1997 staging system.(24)
3. Curative-intent operation feasible and arranged.
4. Eastern Cooperative Oncology Group performance status ≦ 1.
5. A leukocyte count ≧3750/μL, Hb ≧10 g/dL, and a platelet count ≧100,000/μL.
6. A serum bilirubin level \< 1.5 UNL (upper normal limit), serum creatinine level \< 1.5 UNL or creatinine clearance \> 60 mL/min.
7. Age less than 70 years old
8. Informed consent signed.

Exclusion Criteria:

1. Evidence of distant metastatic.
2. Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
3. Presence of uncontrolled hypertension, poorly controlled heart failure.
4. Presence of active infection.
5. Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
6. Women who test positive for pregnancy. Note: Patients received neck lymph node biopsy will be eligible and the stage will be given according to the preoperative status.
Partial Replicated Crossover Clinical Study to Compare Pharmacokinectic Characteristics of Eperisone Hydrochloride and Aceclofenac With HCP1104 Treatment to Those of Co-administration of Eperisone Hydrochloride 50mg Tablet and Aceclofenac 100mg Tablet in Healthy Adult Male Volunteers

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1104 and Eperisone Hydrochloride plus Aceclofenac.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* BMI of \>20kg/m2 and \<28kg/m2 subject
* Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Participation in another clinical study within 60 days prior to start of study drug administration
Clinical Trial of Motilitone on Gastric Motor Function in Healthy Volunteers

The purpose of this study is to compare the effects of Motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* no gastrointestinal symptoms
* no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy
* written informed consent

Exclusion Criteria:

* pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception
* history of abdominal surgery that may influence gastrointestinal motility
* gastrointestinal hemorrhage, mechanical ileus, enterobrosis
* irritable bowel syndrome, inflammatory bowel disease
* severe disturbance of liver, kidney, heart,lung,blood and endocrine
* psychoneurosis, alcoholism, drug dependence
* medications that may alter evaluation of Motilitone including antibiotics,corticosteroids, NSAID within 1 month, prokinetics, H2 blocker, PPI, anticolines, erythromycin, antidepressive agents withing 2weeks
Study of Intragastric pH Profile After 5 Days Pantoprazole 40 mg iv Followed by Oral Esomeprazole 40 mg po or Oral Pantoprazole 40 mg po

This Phase IV study is intended to compare intragastric acid suppression of oral esomeprazole (NEXIUM ® Delayed-Release Capsules) with that of oral pantoprazole (PROTONIX ® Delayed Release Tablets ), in subjects who continue to require acid-suppressive therapy following a course of intravenous (iv) pantoprazole (PROTONIX ® I.V. for Injection).


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Males and females aged 18 to 70 years, inclusive.
* Male or non-pregnant, nonlactating female healthy volunteer subjects. Females must be post-menopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
* Previous enrollment or randomization of treatment in the present study.
* Received an experimental drug or used an experimental device within 28 days preceeding the screening visit.
PREFERS (Preserved and Reduced Ejection Fraction Epidemiological Regional Study) Stockholm Heart Failure Study

Heart failure (HF) with preserved (HFpEF) or reduced (HFrEF) ejection fraction is associated with poor prognosis and quality of life. While the incidence of HFrEF is declining and HF treatment is effective, HFpEF is increasing, with no established therapy. PREFERS Stockholm is an epidemiological study with the aim of improving clinical care and research in HF and to find new targets for drug treatment in HFpEF starting with a cardiac biopsy study in elective CABG patiens.

Patients with new-onset HF (n = 2000) will be characterized at baseline and after 1-year follow-up by standardized protocols for clinical evaluation, echocardiography, and ECG. In one subset undergoing elective coronary bypass surgery (n = 100) and classified according to LV function, myocardial biopsies will be collected during surgery, and cardiac magnetic resonance (CMR) imaging will be performed at baseline and after 1 year. Blood and tissue samples will be stored in a biobank.We will characterize and compare new-onset HFpEF and HFrEF patients regarding clinical findings and cardiac imaging, genomics, proteomics, and transcriptomics from blood and cardiac biopsies, and by established biomarkers of fibrosis, inflammation, haemodynamics, haemostasis, and thrombosis. The data will be explored by state-of-the-art bioinformatics methods to investigate gene expression patterns, sequence variation, DNA methylation, and post-translational modifications, and using systems biology approaches including pathway and network analysis.In this epidemiological HF study with biopsy studies in a subset of patients, we aim to identify new biomarkers of disease progression and to find pathophysiological mechanisms to support explorations of new treatment regimens for HFpEF.

Eligibility Criteria:
Inclusion Criteria:CABG PREFERS

Inclusion criteria:

1. Patients undergoing elective coronary bypass surgery
2. History of heart failure not required
3. Age \>18 years
4. Willingness to participate (written informed consent)
5. Possibility to obtain technically satisfactory echocardiography

Inclusion criteria PREFERS:

1. New-onset heart failure according to ESC guidelines including NT-proBNP \>125 ng/L at heart failure clinic or \>300 ng/L at emergency department visit or hospital admission
2. Age \>18 years
3. Willingness to participate (written informed consent)
4. Possibility to obtain technically satisfactory echocardiography

Exclusion Criteria CABG PREFERS and PREFERS:

1. Cognitive impairment
2. Inability to understand Swedish language
3. Anaemia (haemoglobin level \<90 g/L)
4. Heart failure primarily due to valvular disease, primary right ventricular failure, pulmonary artery hypertension, hypertrophic obstructive cardiomyopathy Infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis, or haemochromatosis)
5. Severe co-morbidity, severe COPD, severe renal dysfunction (eGFR \<30 mL/min/1.73m2). Any other co-morbid disease that will disable the ability to assess or treat heart failure.
Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries

Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.

Patients who will undergo open heart surgery will be included in this study. Pain management is important after coronary artery bypass graft (CABG) surgery. Poorly controlled postoperative pain can trigger myocardial ischemia, increase catecholamine levels, result in increased complications such as stroke and bleeding, and increase the risk of pneumonia. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. For this reason, regional methods are gaining importance in pain treatment. After cardiac surgery. Both sternotomy and bilateral chest tubes are the most painful interventions during cardiac surgeries. Parasternal block can be a good alternative in the treatment of pain in CABG surgeries. In parasternal application, the aim is to anesthetize the nerves innervating the sternum between the pectoral muscle and the intercostal muscle by holding the probe in the parasagittal plane on the lateral side of the sternum under USG guidance. Patients who will undergo open heart surgery will be included in this study. The patients will be divided into two groups, and in Group 1, before general anesthesia is given, bilateral ESPB will be performed at the 4-6th thoracic level in the prone position, and then routine general anesthesia will be performed (at this stage, the patients will be given sedation to prevent them from feeling pain). After endotracheal intubation, in Group 2, a parasternal block will be performed from the lateral sternum. At the end of the surgery, local anesthetic infiltration will be perform to the tube sites. General anesthesia and surgical procedures will be performed routinely in both groups. In the intensive care unit patients will be monitored for pain levels, intubation duration, whether there is atelectasis in the lungs, and the need for reintubation. Pain assessment will be evaluated with the behavioral pain score while the patients are intubated and with the visual pain scale after extubation. Whether atelectasis has developed will be evaluated with ultrasonography at the 12th and 24th hours postoperatively

Eligibility Criteria:
Inclusion Criteria:

1. Patients who will undergo open heart surgery
2. Patients who agreed to participate in the study-

Exclusion Criteria:

1. Patients who do not agree to participate in the study
2. Patients with chronic lung disease
3. Patients with D. Mellitus
Comparison of Bonding Failure Rates of Fixed Lingual Mandibular Retainers in a French Sample Aged 11 or Older, Comparing Prior Enamel Sandblasting With Conventional Pumice Polishing

At the completion of orthodontic treatment, the position of the mandibular canines and incisors is being maintained on a routine basis by bonding a multi-braided wire retainer onto their lingual surfaces. One of the adverse events that might occur with time is the debonding of the wire from one or several lower anterior teeth . This event which can unfortunately get unnoticed by the patient can lead to unwanted tooth displacement. When the practionner detects such a debonding, he has to go through a laborious and lengthy procedure to rebond the wire. When on the other hand the patient notices himself such a debonding, he is to call in emergency his practitioner to get his retainer repaired. This leads to emergency visits that are susceptible to affect adversely his timetable. The prevalence of these bonding failures is estimated at 37% at 18 month follow-ups. It has been reported that with prior enamel sandblasting, bonding failure rate is reduced to 8% at 24 month follow-ups. However, no study has reported yet the debonding rate of lower fixed, comparing wires that have been bonded after prior enamel pumicing to those that were put in place after prior enamel sandblasting.

The expected result of this trial is a significantly decrease in bonding failure rate of mandibular lingual retainer when enamel surfaces are initially sandblasted compared to the ones which are pumiced. This reduction would lower the risk of unwanted tooth movement of mandibular incisors and canines after orthodontic treatment and decrease the number of emergency appointments for the patient and the practitioner.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 11 years of age
* At completion of fixed orthodontic therapy
* Presence of all 6 mandibular canines and incisors

Exclusion Criteria:

* Active decay
* Presence of dental restorations
* Tooth fracture
* Periodontal disease
* Structural anomalies affecting the lingual side of the mandibular incisors and canines
* Cleft lip and palate
* Cranio-facial syndrome
* Inability to obtain the patient informed consent
The Association of hsCRP and Radiotherapy-Induced Toxicity in Patients With Nasopharyngeal Carcinoma

The primary purpose of this study is to explore the association of high sensitivity C-reactive protein (hsCRP) and radiotherapy(RT)-induced toxicity in patients with nasopharyngeal carcinoma. In each patient, hsCRP levels in the pre- and post-RT plasma samples will be measured according to the schedule we set.


Eligibility Criteria:
Inclusion Criteria:

* Patients were pathologically newly diagnosed with nasopharyngeal carcinoma and had no previous history of other tumors
* According to the treatment strategies of doctors, patients need to receive radiotherapy with or without chemotherapy (for example, neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy) or targeted therapy
* Willingness to sign the informed consent and return to enrolling institution for follow-up and data collection

Exclusion Criteria:

* Patients do not conform to the inclusion criteria
* Pregnant or Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Vital organs dysfunction(for example, kidneys, heart, liver, lungs, brain)
* Other contraindications or unsuitable conditions for radiotherapy
Internet Self-Management Program With Telephone Support for Adolescents With Arthritis

This study will evaluate the feasibility of "Teens Taking Charge: Managing Arthritis On-line" intervention that will help adolescents with arthritis to better manage their disease and improve their health-related quality of life (HRQL).

This feasibility study will (1) assess adolescents' willingness to be randomized; (2) pilot the intervention, attention control strategies (e.g., adolescents' 'own best efforts' at managing arthritis), and outcome measures; (3) determine adolescents' perceptions regarding acceptability of the web-based intervention; and (4) obtain estimates of treatment effects in primary (HRQL) and secondary (knowledge, coping, self-efficacy, stress, treatment adherence, pain) outcome measures to inform the calculation of appropriate sample size for the future RCT.

We hypothesize that adolescents with JIA in the web-based intervention will demonstrate: (a) improved HRQL; (b) increased disease-specific knowledge; (c) improved coping, self-efficacy, and adherence to prescribed management; and (d) decreased pain and stress compared to adolescents in the attention control group

Eligibility Criteria:
Inclusion Criteria:

* adolescents 12 to 18 years
* diagnosed with JIA,
* able to speak and read English or French
* able to complete baseline online outcome measures.

Exclusion Criteria:

* cognitive impairment
* major co-morbid illnesses (medical or psychiatric) which may impact their ability to understand and use the web-based program.
Practice of Mechanical Ventilation in Patients With Severe Brain Injury in China

The mechanical ventilation strategy has changed over years worldwide. Several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. In this prospective, multicenter, cross-sectional survey, the practice of mechanical ventilation among patients with severe brain injury will be investigated in 70 intensive care units in China.


Eligibility Criteria:
Inclusion Criteria:

1. older than 18 years
2. with severe brain injury (including severe traumatic brain injury, ischemic stroke, subarachnoid hemorrhage, spontaneous intracerebral hemorrhage, hypoxic-ischemic encephalopathy, intracranial tumor, intracranial infection and idiopathic epilepsy)
3. mechanical ventilated for at least 24 hours before the time of on-spot survey

Exclusion Criteria:

1. undergoing a spontaneous breathing trial (SBT) at the time of on-spot survey
2. underwent at least once SBT in the preceding 24 hours before time of on-spot survey
3. enrolled in another trial
French Travelers' Knowledge of Risk of Acquiring ESBL-PE

Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the risk of acquiring MRE.

Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, The investigators aimed to assess, among persons attending a consultation for travel medicine and international vaccines, patients level of knowledge regarding the risk of acquiring MRE, preventive behaviours and the need to inform health professionals that they had recently travelled if the patients require medical care after their return. A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who attended this consultation between January 2016 and May 2016 and who completed the questionnaire were included in the study. The questionnaire was completed before the planned travel. The travellers answered the questionnaires before seeing the physician.

Eligibility Criteria:
Inclusion Criteria:

* Adult travellers who attended the consultation for travel medicine and international vaccination in Reims University Hospital
* Adult who completed the questionnaire