cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Celsior® in Liver Transplant Preservation.

The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.

The quality of organ preservation is a major determinant of initial graft function and survival. Graft viability is based on hypothermia, the organ being stored in a cold preservation solution.

Celsior® has been shown effective for cold preservation of heart and lung and, in laboratory studies, for liver, kidney and pancreas. The aim of the study is to evaluate the efficacy and safety of Celsior® in liver transplant preservation. Celsior® will be considered effective if the failure rate one year after transplantation is not significantly superior to 20% (rate observed in the European transplantation register between 1997 and 2001).

Eligibility Criteria:
Inclusion Criteria:

* Adult
* Primary liver transplantation
* Whole organ transplantation
* Agreement for a 1 year follow-up
* Informed written consent

Exclusion Criteria:

* Liver disease secondary to clotting abnormalities
* Uncontrolled bacterial or viral disease at the time of transplantation
* Combined transplantations
Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth

The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds) and half-reduced etching time (7 seconds). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.

The aim of this study is to evaluate the effect of shortening the etching time on the 18-month clinical performance of resin composite restorations in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will consist of 70 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal surface. The sample will be randomly divided into two groups according to the etching time of the dentin prior adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be clinically followed every 6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.

Eligibility Criteria:
Inclusion Criteria:

\*Active carious lesion in middle dentin limited to the occlusal surfaces of primary molars.

Exclusion Criteria:

* Children who refuse or fail to cooperate with the completion of clinical procedure;
* Teeth without antagonist;
* Carious lesions in inner half of dentin;
* Presence of painful symptoms or signs of pulpal changes.
Bilateral Essential Tremor Treatment With FUS

Combined Phase II/III, multi-center, prospective, single-blinded trial.

Ten (10) patients with who previously underwent successful and uncomplicated MRgFUS thalamotomy for essential tremor will undergo a contralateral treatment. The incidence of side effects will be determined at 1 and 3 months postoperatively, graded per the CTCAE v5 and analyzed by a data safety monitoring board. Upon successful review, this Phase II trial will be converted to a Phase III trial of utility that will enrol 40 additional patients. The primary outcome will be the change in QUEST score at 12 months postoperatively, as well as a patient-reported assessment of Health Utility. Secondary outcomes will include objective tremor, gait and speech assessments (filmed and scored by blinded evaluators), as well as quality of life questionnaires and adverse events questionnaires. Outcomes will be assessed immediately after the procedure, as well as 1, 3, 12, 24 and 36 months post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years
* The patient has a primary diagnosis of ET or ET plus confirmed by a movement disorder neurologist;
* The patient previously underwent a MRgFUS (\> 6 months ago);
* The tremor on the untreated side negatively impacts the patients' quality of life;
* The patient wants treatment of the contralateral side.

Exclusion Criteria:

* Clinically relevant gait and/or balance impairment (e.g. wide-based, more than 2 falls/months, wheelchair, walker, cane use)
* Clinically relevant speech impairment (e.g. impairment of intelligibility)
* Inability to comply with the follow-up schedule;
* Refusal of the treating physician.
In-depth Survey for the Reasons of Weight Control Difficulties

The aim of this study was to investigate the causes of weight control difficulties in overweight or obese patients .Overweight or obese Chinese patients were enrolled. According to their age, 3 males and 3 females (24 in total) aged 14-20 years, 21-40 years, 41-60 years and 61-80 years were included for interview for about 1 hour. The interview included demographic basic information and other characteristics, time and results of weight control, and causes of weight control difficulties. After collecting the information, classification and summary analysis were performed.

The aim of this study was to investigate the causes of weight control difficulties in overweight or obese patients of all ages by in-depth interview, in order to explore more causes of weight control difficulties, to make early exploration for targeted large-scale cross-sectional survey studies on the causes of weight control difficulties in the future, and to find the causes of weight control difficulties, which will help to study measures to solve weight control difficulties.

Study design: Overweight or obese Chinese patients were enrolled. According to their age, 3 males and 3 females (24 in total) aged 14-20 years, 21-40 years, 41-60 years and 61-80 years were included for interview for about 1 hour. The interview included demographic basic information and other characteristics, time and results of weight control, and causes of weight control difficulties. After collecting the information, classification and summary analysis were performed.

Eligibility Criteria:
Inclusion Criteria:

1. Fully understand the purpose, nature and method of the study, voluntarily participate in the study, agree to record the interview content through a tape recorder during the interview, and sign the informed consent form (ICF) before the interview;
2. Chinese aged 14-80 years (including boundary value, subject to the time of signing the informed consent form), male or female;
3. Patients with body mass index (BMI) greater than 24 kg/m 2 , who have taken any weight control measures;
4. Willing and able to comply with study requirements. -

Exclusion Criteria:

1. Inability to communicate in speech; 2. Known mental or psychological disorder of any kind; 3. Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.

-
Cell Distribution in Induced Sputum in Patients With Asthma

The aim of this case-control study is the comparison of the cell distribution in induced sputum in young adults with asthma and in healthy controls.

The study consists of two visits. At both visits subjects are asked to perform a lung function test (body plethysmography) and levels of exhaled nitric oxide (eNO) are measured. At the first visit a blood sample is drawn to determine the inflammatory and allergic status of the subjects and the sputum is induced by an ultrasonic nebulizer. At the second visit another sputum sample is induced by a nozzle nebulizer. The cell distribution will be evaluated in both sputum samples.

Objectives:

The aim of this study is the characterization of healthy children/ young adults and matched patients with asthma in terms of lung function, and the degree of the systemic and bronchial inflammation.

Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) and by a cytometric bead assay (CBA). Components of the innate immune system (mannose-binding protein, TLR recognition proteins and surfactant proteins) are determined from sputum or blood respectively.

Methods and Work Programme:

This study consists of two study visits (V1 and V2)

V1 (day 0 - duration 1 hour):

* Measurement of exhaled nitric oxide (eNO)
* Lung function testing with and body plethysmography
* Blood test: blood count, CRP, RAST, serum inflammatory mediators, markers of the non-specific pulmonary defense system
* Induced sputum attained by an ultrasonic-nebulizer for inflammatory mediators and microbiological investigations

V2 (day 14-28 - duration 1 hour):

* Measurement of nitric oxide in expired air (eNO)
* Lung function testing with spirometry and body plethysmography
* Induced sputum attained by a nozzle-nebulizer for inflammatory mediators and microbiological investigations

Study population:

Children, adolescents and young people (6 - 25 years of age). Both the patients and the healthy subjects are recruited from the outpatient clinic of Pediatric Allergy and Pulmonology.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 6 and 25 years of age
* Known bronchial asthma/no bronchial asthma(depending on the study group)
* Ability to perform lung function tests and inhalation

Exclusion Criteria:

* \< 6 and \> 25 years of age
* Any acute condition with systemic or bronchial inflammation
* any chronic condition or infection (e.g. HIV, tuberculosis, malignancy)
* pregnancy
* known alcohol and/ or drug abuse
* Inability to understand the extent and scope of the study
* Participation in another study
Volume of Perirenal Fat and Chronic Kidney Disease

The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and fibrosis in its environment. This study aims to measure the influence of the tumor on his kidney Environment and fat and define molecular markers not influenced by renal tumor. The main objective is to compare the inflammation of the perirenal fat taken in two locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his own control. The secondary objective is to compare the degree of interstitial fibrosis of the renal cortex in the same sampling methods.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Indication nephrectomy for kidney tumor
* Stadium T1a, T1b or T2 and M0 according to the TNM (Tumor Nodes Metastasis) classification of tumors

Exclusion Criteria:

* Nephrectomy indication for chronic pyelonephritis
* Asian topic because of the difference threshold values used to characterize the metabolic syndrome in this population
* Diabetes type I or II due to a high score of renal interstitial fibrosis
* Infection with HIV (Human immunodeficiency virus)
* Partial nephrectomy (a part of the kidney on the side of the tumor is left in place)
TNF Polymorphism and Implantation Rate

Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro fertilization (IVF) in women without female infertility factor ?

This study was performed in order to verify whether TNF-308 allele was associated with a higher implantation rate and multiple pregnancy rates in women without known infertility factors after ovarian hyperstimulation with exogenous FSH for IVF

Eligibility Criteria:
Inclusion Criteria:

* Women
* normal karyotype,
* age under 38 years
* serum follicle-stimulating hormone (Day-3 FSH) levels below 10 UI/l

Exclusion Criteria:

* age under 18 years
Oral Health and Its Relation to Development and Well-being of Schoolchildren Before and After Restorative Treatments

The present study aims evaluate the oral health conditions of schoolchildren and its relation to growth, development and well-being. Also, it seeks to evaluate different restorative interventions performed at school premises in primary teeth and its impact on the quality of life.

Schoolchildren, aged 6-8 years old, from the six public schools of a deprived suburban area of Brasília, Brazil will be recruited. In the stage 1 of the study, an epidemiological survey of the oral health status and an anthropometric evaluation of the children will be performed. Potential patient for study's stage 2 will be recruited. Quality of life surveys, patterns of oral hygiene and socio-demographic data will be collected.

Children with restorative treatment needs will be included in the study's stage 2. In this second stage, primary molars with deep dentin lesions will be treated according to two techniques for selective excavation of carious dentin: subjective criteria or using an objective criteria (polymer burs). For both groups restorations will be performed using a high-viscosity glass-ionomer. In shallow and medium depth dentin lesions, carious dentin will be excavated using hand instruments only (ART approach) and restored using two materials: a high-viscosity glass-ionomer or a combination of a self-etch adhesive and a bulk fill composite.

All children will be followed up (study's stage 3) to assess efficacy of the restorative interventions and impact of the restorative treatment on children's quality of life and development.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-8 years old;
* Good general health;
* minimum one cavitated dentin carious lesion in a primary molar with sensible asymptomatic pulp.

Exclusion Criteria:

* participating in other study;
* plan to move or not residents;
* systemic disease or general disability;
* expected limited compliance; known allergy to study material; expected exfoliation of primary molars within 18 months.
Estimating Volume Using LiDCO

We hypothesize that the stroke volume variation measured using the commercially available LiDCO monitor provides a reasonable estimate of volume when compared to standard measures. This study will collate data that is already being collected by the bedside nurses.

Objective: To compare measurement of stroke volume variance with intake/output measurements, weight, BUN/Creatnine values, and central venous pressure.

Design: Non-experimental, non-randomized observational comparative study.

Setting: The sixteen bed Neurocritical Care Unit at Duke University Hospital.

Patients: 45 adult (over 18 years) subjects with intracranial pathology who require volume resuscitation. Only patients with current LiDCO monitoring will be considered eligible for inclusion in the study.

Interventions: This is an observational study. Subjects will receive standard-of-care treatment without additional intervention.

Data Analysis: All data will be collected by the principal investigator / study coordinator. Personal patient information will be removed (deidentified) from the permanent data collection records to protect patient confidentiality. Data collected will be entered into a Microsoft Excel electronic spreadsheet and will be saved on a USB Disk drive to be stored in a locked cabinet in the investigator's office. Statistical analysis using SAS v9.1, (Cary, NC) will be conducted with a level of significance set at .05 (alpha) using standardized comparative analysis techniques.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the neurocritical care unit have an arterial line in place already connected to LiDCO monitor Physician order for monitoring intake and output

Exclusion Criteria:

* pregnant females
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer

This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.

Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.

The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.

The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female aged 20 to 50 with a body mass index(BMI) between 19 and 27 kg/m2
2. Acceptable medical history, physical examination, laboratory tests and EKG, during screening
3. Provision of signed written informed consent •20\~50 yrs old, healthy Korean Subjects

Exclusion Criteria:

1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.

4. Administration of other investigational products within 90 days prior to the first dosing.

5. Administration of herbal medicine within 30 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).

6.Have AST(SGOT) or/and ALT(SGPT) \> 3 times of normal upper limit at the time of screening 7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs.
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder

The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).


Eligibility Criteria:
Inclusion Criteria:

* The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.
* The patient has completed the 031-11-002 study (the patient has visited the hospital during week8)
* Inpatient or outpatient status

Exclusion Criteria:

* The patient is currently diagnosed with another disorder on the autism spectrum in DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative Disorder, or Fragile-X Syndrome.
* Patients who fall under a contraindication listed in the ABILIFY package insert
* Others
Pilot Study of ILIADE : Exploring Health Literacy Within Patients Hospitalized for Acute Cardiovascular Events

Health literacy (HL) is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. Health literacy is known as a health determinant. An association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization or emergency visits, low medication adherence and poor health status.

These have been particularly demonstrated with cardiovascular diseases, which combine risk factors (emergency hospitalization, reduction in the length of hospital stays, and complex secondary preventive drug treatments). Despite many scientific international literature about health literacy and health outcomes, no information is available in France on the prevalence of low health literacy level of patients, notably cardiovascular patients. The investigating team's hypothesis is that knowing the prevalence of low HL levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-HL patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations.

The first aim of the present study is to estimate the prevalence of low HL level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. Secondary aims are to assess factors associated with the level of HL and identify barriers and facilitators of low HL patients to understand medical information on their disease. The results of this study will guide the design of the intervention of an interventional study on HL of cardiovascular patients.


Eligibility Criteria:
Inclusion Criteria:

- Patient

* Age greater than or equal to 18 years
* Hospitalization for Acute coronary syndrome (ACS) (myocardial infarction with or without ST segment elevation) or acute attack of heart failure (systolic or diastolic)
* Able to communicate in French and/or helping to communicate in French
* Return home after hospitalization

Health professional

* Voluntary and available for the entire interview
* Having participated in the management of the patient screened on the day of the consultation
* Cardiologist, intern or emergency department nurse
* Attached to the participating service

Exclusion Criteria:

- Patient

* Short-term vital prognosis
* Severe dementia
* Inability to manage drug treatment alone
* Institutionalization at the end of hospitalization

Health professional

* Health professional working in the department only one or two days a week
* Health professional who is not specialized in diseases of interest