cyrilzakka/clinical-trials huggingface dataset:
Hemoglobinopathy Nursing Program and Pediatric Nursing Students

Hemoglobinopathies are the most common life threatening, monogenic disorders in the world. The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim: This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric nursing students' performance.


Eligibility Criteria:
Inclusion Criteria:

* pediatric nursing students registered for the academic year 2016/2017

Exclusion Criteria:

* Any student had personal or family history of hemoglobinopathies
Olfactory Function and Postoperative Cognitive Dysfunction

To study the correlation of POCD with olfactory function. To explore whether enhanced olfactory stimuli can reduce the risk of POCD as a preventive strategy.

Postoperative cognitive dysfunction (POCD), the most common complications of geriatric surgical patients, could contribute to long-term social dysfunction, high mortality and increased medical cost. Previous studies have suggested that impaired Olfaction was related to postoperative delirium (Nadya M. Dhanani et al, J Clin Anesth 2012; Charles H. Brown IV et al, J Am Geriatr So 2015; Min Seung Kim et al, J Neural Transm 2016). However, there is still no efficient treatment for POCD, and it also remains largely unknown whether enhanced olfactory stimuli can be used as an inventive strategy to reduce the risk of POCD.

Eligibility Criteria:
Inclusion Criteria:

1. Keen surgery under general anesthesia;
2. Age is greater than or equal to 65 years old;
3. Han Nationality, mother tongue is chinese;
4. The MMSE score: Illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points;
5. Being able to complete the assessments without serious visual or hearing difficulty;
6. Without serious heart, brain, liver, kidney, lung and other organs;
7. Without serious neurological and psychiatric disorders, such as Alzheimer's disease, Parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.;
8. The ASA class I or II;
9. The people signed informed consent.

Exclusion Criteria:

1. Had severe head and face disease, trauma history or history of surgery;
2. Had a history of influenza in 3 weeks;
3. The serious body disease and tobacco, wine and other substance abuse history;
4. The presence of malignant tumor with shorter survival disease.
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects

The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.


Eligibility Criteria:
Inclusion criteria:

- Healthy male and female subjects

Exclusion criteria:

- Any relevant deviation from healthy condition.
Randomized Double-Blind Placebo-Controlled Crab or Shrimp Allergy Reduction Study Using Nambudripad Allergy Elimination Techniques

Purpose of this study is to determine whether NAET procedures are effective in the treatment of crab or shrimp allergy.

Hypothesis: experimental group will show a significant improvement over the control group in allergic symptom, serum crab- or shrimp-specific IgE and skin test for crab or shrimp extract.

Nambudripad allergy elimination techniques (NAET) were developed by Dr. Devi Nambudripad in 1983. Many patients have been relieved of allergy and allergy-related disease by this treatment.

Lack of well-controlled clinical study prevents NAET from being accepted as a treatment option in current medical system.

The aim of this project is to conduct a double blind-placebo controlled study of applying NAET to treat crab or shrimp allergy.

The parameters to be measured are allergic symptom, crab- or shrimp-specific IgE and skin test before and after NAET treatment

Eligibility Criteria:
Inclusion Criteria:

* Older or equal to 20 years old
* History of allergic to crab or shrimp
* Positive serum crab- or shrimp-specific IgE

Exclusion Criteria:

* History of anaphylactic shock
* On medication of anti-histamine or steroid
* Pregnancy
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)

Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease.

The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS
* Local recurrences are allowed
* Age ≥ 18 years
* Able and willing to undergo tumour biopsies or tumour sampling during surgery
* Localization of sarcoma enables safe biopsy or surgery
* Written informed consent

Exclusion Criteria:

* Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist)
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study
Trevo® Retriever Registry Post Market Surveillance

The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:

1. Day 90 mRS assessment
2. Day 90 all cause mortality
3. Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
4. Rates of device and procedure related serious adverse events (AEs)

Eligibility Criteria:
Inclusion Criteria:

* Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
* Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
* Signed Informed Consent obtained
* Subject willing to comply with the protocol follow-up requirements
* Anticipated life expectancy of at least 3 months

Exclusion Criteria:

* The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.
Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Eligibility Criteria:
Inclusion Criteria:

* female patient.
* more than 18 years.
* undergoing elective gynecologic laparoscopic surgeries.

Exclusion Criteria:

* allergy to local anesthesia.
* contraindication to spinal anesthesia.
* Significant cardiac, liver or renal dysfunction.
* Inability to informed consent
Cardiac Output Monitoring to Predict Pre-Eclampsia and Restricted Growth (COMPaRE)

Pre-eclampsia (PET) and fetal growth restriction (FGR) are common complications of pregnancy that affect up to 15% of pregnancies in the UK. These conditions can have potentially devastating consequences to mothers and babies in pregnancy. Pre-term birth, that is often medically indicated to treat severe PET and FGR can cause cerebral palsy, breathing difficulty, developmental delay and even death in affected babies. Mothers who suffer from PET are at risk of seizures, strokes, multi-organ failure and future chronic hypertension. It is now thought that PET and FGR may result from poor adaptation of the maternal cardiovascular system to normal pregnancy. This project aims to study the patterns within the maternal cardiovascular system and haemodynamic profile in women who are at high risk of PET and FGR by using non-invasive methods to gather information about the functions of their hearts and major blood vessels. The investigators hope to elucidate the patterns that may offer an early warning to mothers who may develop PET and whose fetuses may be growth restricted. This would be an opportunity to more closely monitor, modify risk factors and treat earlier women who develop these conditions. Women who are at a high risk of PET and FGR as stipulated in the relevant Royal College of Obstetrics \& Gynaecology and National Institute of Clinical Excellence guidelines and who give their consent will be eligible for the study.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged ≥18 at time of conception
* Case subjects are at high risk of PET by NICE guidelines ( ≥1 high risk factor or \>1 moderate risk factor) or high risk of SGA by RCOG Guidelines (≥1 major risk factor or ≥3 minor risk factors). Control subjects do not meet this criteria

Exclusion Criteria:

* Maternal age \<18 years of age at time of booking
* Fetal structural or genetic abnormality
* Multiple pregnancy
* Known underlying maternal cardiac condition
Observational Study for Lung Cancer Patients Treated With Nivolumab

This study will describe the characteristics of patients initiating nivolumab treatment for lung cancer and their outcomes over 3 years in France


Eligibility Criteria:
Inclusion Criteria:

* Male or female: 18 age at the time of nivolumab initiation
* Pathologically confirmed diagnosis of lung cancer
* Patient initiating nivolumab :therapeutic decision to initiate nivolumab must be taken by the physician prior to enrolling a patient in the study

Exclusion Criteria:

-Patient taking part in an interventional study for lung cancer treatment for which nivolumab is 1 of the investigational drugs

Other protocol defined inclusion or exclusion criteria could apply
The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction

To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.

The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10\^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.

A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years old
* Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
* Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol \> 200 mg/dL or low-density lipoprotein cholesterol \> 130 mg/dL or triglycerides \> 130 mg/dL), high-density lipoprotein cholesterol \< 40 mg/dL
* If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
* Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form

Exclusion Criteria:

* History of diabetic ketoacidosis
* Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
* Occurrence of acute infectious diseases within the last month and antibiotic use for \> 7 days
* Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
* Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
* History of any cancer or undergoing cancer treatment in the past 5 years
* Abnormal liver function (GOT or GPT greater than 3 times the normal upper limit) or liver cirrhosis
* Impaired kidney function (eGFR \< 30 mL/min/1.73 m2)
* History of alcohol abuse
* Participation in any other interventional clinical research within the last month
* Pregnant and breastfeeding women
* History of allergy to the investigational product
* Participants deemed unsuitable for inclusion by the principal investigator
The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery

Enhanced recovery after surgery (ERAS) protocols have been widely applied during perioperative periods for different diseases, there are few reports of ERAS in patients undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the benefits of ERAS protocol compared to traditional care following ESS.


Eligibility Criteria:
Inclusion Criteria:

* The patient has CRSwNP need endoscopic sinus surgery for treatment.

Exclusion Criteria:

* age under 18 years
* pregnant
* ASA grade IV
* received oral or topical steroids within 4 weeks preceding surgery
* had previous ESS history
* intolerant to NSAIDS
* comorbidity of severe mental disease
* not compliant with therapy.
Nasal and Oronasal Mask in Severe OSA Patients With Nasal Free Airflow of Obstruction

The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous positive airway pressure (CPAP) is the first choice of treatment in severe OSA. However, the adherence to CPAP varies, and the interface between patient and the CPAP may interfere with adherence, comfort and efficiency as well as in sleep variables. Objectives: (1) to determine if self-reported airflow route (nasal or oronasal airflow) is the same as the route determined in a laboratory analysis in controls (healthy subjects) and severe OSA patients with nasal free airflow of obstruction during asleep and awake, (2) to compare the effects of nasal and oronasal CPAP titration (randomized order of masks, 14 days apart) on apnoea-hypopnoea index, CPAP level, PSG variables - including analysis for body positioning, the airway defense mechanisms (nasal mucociliary clearance, mucus properties, citology and inflammation in nasal lavage fluid) and systemic effects (serum miRNA expression and cytokines), (3) CPAP adherence after 1 month and 12 months.

After agreement with the written informed consent, 30 volunteers (10 healthy volunteers and 20 patients with severe OSA), male and female, aged \> 21 years were recruited in the Sleep Laboratory of Hospital das Clínicas da Faculdade de Medicina (FMUSP). The volunteers were evaluated at the Sleep Laboratory (Incor) in two phases. First Phase: volunteers were assessed for breathing route awake and asleep (including respiratory events in OSA patients) and were indicated as nasal breathing and oronasal breathing. Second phase for OSA patients: two manual full-night CPAP titration with nasal and oronasal masks in a randomized order, 14 days apart. Data and fluids were analyzed before and after both titration studies comparing both masks including supine and lateral position during asleep and CPAP titration. Third phase for OSA patiens: patients were treated with the best interface found in CPAP titration study during 30 days and patients were assessed for sleep quality, excessive sonolence during the day, airway symptoms, airway defense mechanisms biomarkers (mucociliary clearance, mucus properties, citology, inflammation cytokines and adhesion molecules and others) and serum cytokines and miRNA.

Eligibility Criteria:
Inclusion Criteria:

* \>21 years
* moderate or severe obstructive sleep apnea
* nonsmokers
* ex smokers (cessation \>12 months)

Exclusion Criteria:

* infection / acute respiratory inflammation (30 days after to study entry)
* history of fixed nasal obstruction
* nasal or upper airways surgery
* chronic diseases without optimized treatment
A Study To Evaluate The Efficacy Of Eplerenone Compared With Losartan For The Treatment Of Patients With Mild To Moderate Hypertension

The purpose this study is to compare the efficacy of eplereonone and losartan in patients with mild to moderate hypertension.

This Phase 2 study EPLA-0501-072 (A6141012) was conducted beginning 02 April 2003 and was prematurely terminated due to poor enrollment on 12 September 2003. There were no statistical analyses of efficacy conducted because the numbers of patients enrolled were insufficient for inferential analysis due to the poor enrollment. There were no serious adverse events or deaths reported during the study.

Eligibility Criteria:
Inclusion Criteria:

* History of mild to moderate hypertension, or newly diagnosed hypertension, defined as seDBP ≥90 mmHg and \<110 mmHg and seSBP \<180 mmHg
* Withdrawal of all previous antihypertensives prior to the single-blind placebo run-in period and the double-blind treatment period

Exclusion Criteria:

* Secondary hypertension (e.g., renal, renovascular, or adrenocortical disease, pheochromocytoma, Cushing's syndrome, primary aldosteronism, iatrogenic), severe hypertension, or malignant hypertension
* The patient cannot withdraw from antihypertensives by any route including diuretics, alpha-blockers, betablockers, calcium channel blockers, ACE-I, ARB, or other medications affecting blood pressure; patients who have stable angina and have not had their nitrate dosage changed within the past three months (i.e., on a stable maintenance dose) are eligible for this study; sildenafil citrate, theophylline, or papaverine must not be taken within 24 hours prior to a clinic visit
The Dose of Sugammadex for Rapid Reversal of Profound Neuromuscular Block in Young and Elderly Patients

To find out the dose of sugammadex for recovery of the TOF ratio to 0.9 within 2 minutes from profound rocuronium-induced neuromuscular block in young and elderly adult patients.

A previous study reported that elderly patients required a longer time to recover from rocuronium induced neuromuscular block compared to younger patients. Therefore, the aim of this study is to find out the dose of sugammadex for rapid recovery from profound neuromuscular block in young and elderly adult patients.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years or ≥70 years ASA class I-II patients who received surgery less than 2 hours.

Exclusion Criteria:

* anticipated difficult intubation
* neuromuscular, hepatic or renal disorders
* drug allergy
* body mass index \>30 kg/m2 or body mass index \<18 kg/m2
* emergency surgery
Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

This study will assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteer and evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. Additionally, this study will explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

This is a single-center, open-label, randomized, two-period, crossover study in approximately 14 healthy subjects. The goals of this study are as follows:

To assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteers.

To evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine.

To explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the Investigator, are healthy as determined by medical history, physical examination, and 12 lead ECG
* Adult males/females aged 18 to 55 years inclusive
* Male and female subjects of childbearing potential must practice effective contraception during the study and up to 90 days after their last dose.

Exclusion Criteria:

* History of malignant disease, including solid tumors and hematologic malignancies.
* History of clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
* Treatment with prescription medication and/or over-the-counter products and herbal-containing and/or alternative health preparations and procedures.
* Surgery within 90 days prior to check-in.
Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years

The aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.

Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.

Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis.

Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests.

For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity.

The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia.

The secondary aim is to determine the influence of early antibiotic treatment of early disseminated LB on serological results in children with LB in Slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study.

Eligibility Criteria:
Children younger than 18 years with early disseminated Lyme disease:

* multiple erythema migrans
* peripheral facial nerve palsy
* lymphocytic meningitis