cyrilzakka/clinical-trials huggingface dataset:
Impact of the Introduction of a Gastro-intestinal Panel by Polymerase Chain Reaction (PCR).

Evaluation of the impact of the introduction of multiplex PCR panels on the clinical management of patients with gastroenteritis at the University Hospital of Lausanne, Switzerland.

Gastrointestinal multiplex PCR panels have been introduced in clinical practice several years ago, but the impact on the management of patients is yet unknown. The investigators are interested to evaluate if the multiplex PCR panels introduced at the University Hospital of Lausanne in July 2017 modified the usual medical care and in particular the prescription of anti-infectious treatments. The high sensitivity of the multiplex PCR panels should allow a more precise diagnosis of the etiology of the gastrointestinal symptoms of the patients than the traditional methods of stool culture and microscopy. The investigators expect therefore to observe a modification of the proportion of patients receiving anti-infectious treatment, but it is uncertain if it will lead to an increase or a decrease in the use of antibiotics. On one hand antibiotics could be prescribed more often due to a greater and faster detection of enteropathogens. On the other hand antibiotics could be prescribed less often due to more precise diagnosis, showing that viruses and certain bacteria do not require antibiotic treatment.

Eligibility Criteria:
Inclusion criteria:

Ambulatory patients who consulted the University Hospital of Lausanne between July 2016 and May 2017, and were investigated by traditional methods (stool microscopy and culture).

Ambulatory patients who consulted the University Hospital of Lausanne between July 2017 and May 2018 and had stool investigations by a gastro-intestinal panel.

Exclusion criteria:

Patients for whom there ia record in the file that they do not accept that their data are used for research purposes.
Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese subjects
* BMI (Body Mass Index) between 18.0-27.0 kg/m\^2 inclusive

Exclusion Criteria:

* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening
* Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
* History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
* History of significant allergy or hypersensitivity
* Known or suspected allergy to trial product or related products
* History of drug or alcohol abuse
* The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
External Evaluation of Vancomycin Population Pharmacokinetic Models

All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.

Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in Brest University Hospital,
* treated with vancomycin and receiving pharmacological monitoring
* between 1rst January 2019 and 1rst January 2021

Exclusion Criteria:

* Missing data on vancomycin administration
* Refusal to be included in this study
* Hospitalisation in ICU
TL1A Expression in Psoriatic Skin

TL1A is a newly discovered signal molecule that may be crucially involved in the maintenance of chronic inflammatory disorders. TL1A has also been demonstrated in psoriatic skin but the importance of TL1A in psoriasis is still unknown. Understanding inflammatory signal molecules in psoriasis is important because the development of new drugs directed against relevant signal molecules (e.g. TNF-α and IL12/23) has proved to be a very efficacious treatment principle. However, despite the dramatic progress in therapeutic options during the last decade, there is still a fraction of patients that are insufficiently treated with the currently available therapies. TL1A has been claimed to be the next important target for development of biologics in the field of chronic inflammation.

Psoriasis is a common autoimmune disease; affecting approximately 2 % of the western population. Among these 15% are estimated to have severe disease that requires systemic therapy with e.g. methotrexate, cyclosporine or acitretin that are all drugs associated with high frequencies of side-effects. In contrast to this the recent development of the biologic drugs has provided very efficacious and in general well-tolerated new therapeutics. But even with these newer drugs treatment-failures exist and for this group new treatments are needed TNF-like ligand 1A (TL1A) is a novel member of the TNF family of cytokines. Increasing evidence suggests that in addition to TNF-alfa and IFN-gamma psoriasis is also an IL-23 and IL-17 dependent disease so TH1 and TH17 T cells are suggested to be important in driving the disease. Therefore TL1A, which through binding to DR3 influences TH1 and TH17 T cell differentiation, could be an important cytokine in the early inflammatory process in psoriasis. Recently expression of TL1A in psoriatic skin lesions has been demonstrated but the importance of this remains to be investigated.

TL1A exists in both a membrane bound- and a soluble form and is secreted from antigen presenting cells (APCs) such as monocytes, dendritic cells and macrophages in response to stimulation with immune complexes, bacteria or cytokines (TNF-alfa and IL-1beta). Membrane bound TL1A has also been described in T cells. Recently, a new isoform of soluble TL1A (TL1A(V84-L251)) was discovered with functional differences to TL1A(L72-L251. It's unknown whether this isoform is present in psoriatic skin.

Research on TL1A has focused on autoimmune diseases where immune complexes are formed, e.g. rheumatoid arthritis. However, studies have suggested that early pathogenesis in psoriasis could dependent on formation of large complexes between bacterial DNA and the anti-microbial peptide LL-37 which induce cytokine secretion from APC. Cytokines that could lead to TL1A excretion. Whether TL1A can be secreted in this way is unknown.

Eligibility Criteria:
Inclusion Criteria:

* Plaque type psoriasis
* at least 6 month history of psoriasis

Exclusion Criteria:

* systemic anti-psoriatic medication
* topical anti-psoriatic medication (wash-out period 2 weeks)
Mesalamine in Environmental Enteropathy

Undernutrition is one of the most important health issues in Kenya. Children who are chronically undernourished do not reach their full potential and are at increased risk of infectious disease. Stunting occurs in a third of Kenyan children and has severe and long-term consequences in terms of health, development, and poverty. Several studies have shown that stunting is frequently associated with subclinical inflammation of the bowel, a condition referred to as Environmental Enteropathy (EE), previously known as 'tropical sprue' or 'tropical enteropathy'. EE is clinically similar to childhood inflammatory bowel diseases (IBD), including Crohn's disease. The treatment of IBD routinely involves provision of gut immunomodulatory agents, but this approach has never been tried in EE.

This proposal outlines a pilot double-blind randomised placebo-controlled trial of mesalamine (also called mesalazine - the safest immunomodulator used in IBD with least systemic activity) in treatment of severely malnourished children with EE.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 5 years old.
* Provision of informed consent by parent or guardian.
* Stunting (height for age z score \<-2)
* Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema).
* Eligible for outpatient management of malnutrition (i.e. no evidence of acute infection, and passes 'appetite test' according to national guidelines).
* Evidence of chronic inflammation (elevated erythrocyte sedimentation rate, ESR \>20mm/hr).

Exclusion Criteria:

* Known HIV disease or tuberculosis.
* Known previous renal disease or asthma.
* Known allergy or hypersensitivity to mesalamine, other salicylate drugs, or any of the product ingredients.
* Biochemical evidence of acute renal or hepatic impairment on screening blood tests.
* Thrombocytopenia
* Recent (previous two weeks) bloody diarrhoea.
* Concurrent medication known to interact with the study drug (non-steroidal anti-inflammatory drugs, ranitidine, proton-pump inhibitors)
* Acute infection requiring treatment, e.g. lower respiratory tract infection or febrile illness.
* Other reason at the discretion of the attending clinician (independent of the trial team).
Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 001

The clinical trial was designed to evaluate the safety against Group ACYW135 Meningococcal Polysaccharide Vaccine of Hualan administered on subjects 2 years of age and older.

Complying with requirements of the approval letter of clinical trial issued by SFDA (Approval Letter No.: 2006L01017), Hualan conducted phase I clinical trial of Group ACYW135 Meningococcal Polysaccharide Vaccine. The safety end points were the presence of any systemic, local and adverse reaction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
* Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
* Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
* Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
* Axillary temperature ≤37.0℃.

Exclusion Criteria:

* Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
* Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
* History of neurologic symptom or signs;
* Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
* History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
* History of receiving other vaccines or immunoglobulin injection or any research drugs;
* Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
* History of fever within the past 3 days (axillary temperature ≥38.0℃);
* Participating in another clinical trial;
* History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
* Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
* Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome);
* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
* Pregnancy;
* Any condition that, in the judgment of investigator, may affect trial assessment.
Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis

The values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). Another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT). In recent studies it has been clearly shown that PCT is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. Aim of this open, prospective study is therefore to investigate if PCT has an accurate diagnostic value for the diagnosis of acute appendicitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of appendicitis

Exclusion Criteria:

* Antibiotic therapy
* Infection at other body sites
* Age \< 14 years
* Appendectomy in the medical history
Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China

This study aims to develop a life review program and test its effectiveness on a sample of patients with advanced cancer patients receiving palliative care at home in Fuzhou.

A life review program is mainly developed based on Erickson's theory, Confucius's teaching on human development, and the empirical findings of the researcher's preliminary study and pre-pilot study. The program covers reviewing a life for advanced cancer patients and formulating a booklet for them. A randomized controlled trial will be adopted for evaluation of this program. Eligible patients will be randomly assigned to the experimental group and the control group. The subjects in the experimental group will receive a life review program for three weeks. The outcome measure is quality of life (QOL), including domains of physical discomfort, food-related concerns, health care concerns, support, negative emotions, sense of alienation, existential distress and value of life. Subjects' QOL will be assessed before commencement of the program (T0) and one day (T1) and three weeks (T2) after the completion of the program for all subjects in two groups. Perceptions of the program will be elicited within three days after the program for subjects in the experimental group.Descriptive statistics will be used to analyze patients' personal information, disease related information, functional performance and QOL of advanced cancer patients. Repeated measures ANOVA will be used to measure QOL differences in between-group, within-group and interaction effects. Content analysis will be used to analyze the qualitative data collected.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are newly admitted to the study hospice
2. Patients who are suffering from cancer with metastasis made by a physician
3. Patients who know their diagnosis, prognosis and therapy
4. Patients' functional performance (the score of KPS) at or more than 50%
5. Patients who are adults (≥18 years old)
6. Patients who have no cognitive and verbal communication impairments

Exclusion Criteria:

1. Patients with planned treatments, such as chemotherapy, radiotherapy or surgery
2. Patients with psychiatric disorders
3. Patients who live outside Fuzhou since the following-up home visit services are not extended to those areas
Comparison of Brain Volumes Measured by 2D USG and MRI

Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.

All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams
* Born in our hospital
* Alive during discharge

Exclusion Criteria:

* congenital anomalies
* cranial bleeding
* early death
Effects of High Caffeine Content Coffee on Blood Pressure in Young Adults

The purpose of this study is to help further the understanding of the effects of commercially available high-caffeine containing coffee on blood pressure in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Male or Female
* No prior diagnosis of hypertension
* No prior chronic disease requiring medical intervention
* Ability to demonstrate correct usage of ambulatory blood pressure monitoring device

Exclusion Criteria:

- Age less than 18 years old

* Prior chronic disease (such as hypertension) requiring medical intervention
* Previously undiagnosed hypertension
* Intolerance or allergy to coffee or caffeine
* Inability to demonstrate correct usage of ambulatory blood pressure monitoring device
* Inability to complete the required abstinence period prior to study interventions
* Known pregnancy
* Use of birth control
* Tobacco use
* Participation in other investigational drug studies at the time of this study
* Medical illness requiring medical or symptomatic management
The Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men

The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.


Eligibility Criteria:
Inclusion Criteria:

* A signed informed consent to participate in the study
* Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
* Presence of the metabolic syndrome according to the IDF definition

Exclusion Criteria:

* Patients under 35 or above 70 years.
* Participation in any clinical study within 30 days before the first injection of the drug
* Simultaneous participation in another clinical study
* Incapable subjects as well as prisoners
* Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
* Prostate cancer, breast cancer or suspicion thereof
* Presence or history of hepatic tumors
* Acute or chronic hepatic disease
* Presence of renal diseases with renal failure
* Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion
* Suspected lack of the patient's compliance
* Hypersensitivity to the active substance
Polyurethane Foam on the Sacrum for Prevention

The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
* Patients or legal guardians who give their consent to take part in the study

Exclusion Criteria

* Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
* Patients with peri-prosthetic or pathological fractures
* Patients with diaphyseal or distal femoral fractures
High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), 6MWT Assessed at High Altitude (3200m) vs Low Altitude (760m)

To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on 6-minute walk distance (6MWD)

This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \>30 mmHg who permanently live at HA \>2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m and on day 2 and 7 at 760 m after relocation

Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
The Effects of Inspiratory Pressures on Diaphragmatic Contraction in People After Stroke

This is a cross-sectional study to determine the optimal inspiratory muscle training (IMT) intensity for stroke survivors. Participants will breathe through a pressure threshold inspiratory loading device with varying loads in random order. Each IMT intensity protocol consists of 10 breaths. During the test, accessory inspiratory muscle activity will be measured with surface electromyography (sEMG) and diaphragm thickness will be used to assessed with ultrasonography. Repeated-measures ANOVA will be used for statistical analysis to determine the most effective training intensity for future study.


Eligibility Criteria:
Recruitment of participants after a stroke:

The inclusion criteria are:

* clinical diagnosis of ischemic and/or hemorrhagic stroke.
* age ≥ 18 years.
* duration of stroke ranges from 1 month to 12 months after diagnosis.
* had no facial palsy, which could prevent proper labial occlusion.
* had not undergone thoracic or abdominal surgery.
* could understand and follow the verbal instruction.
* stable cardiac conditions.
* no previous history of respiratory problems.

The exclusion criteria are:

* acute myocardial infarction or acute heart failure.
* acute pain on chest or abdominal.
* with the clinical signs of significant pulmonary disease.
* consciousness impaired.
* patient with nasal feeding tube, tracheal tube and/or any condition, which prevent the measurement or training.

Recruitment of healthy participants:

The inclusion criteria are:

* age ≥ 18 years.
* had not undergone thoracic or abdominal surgery.
* no previous history of respiratory problems.

The exclusion criteria are:

* acute myocardial infarction or acute heart failure.
* acute pain in the chest or abdominal.
* with the clinical signs of significant pulmonary disease.
* unstable hypertension, arrhythmias, or unstable cardiovascular conditions, such as fluctuations in blood pressure and heart rate, indicate poor cardiac prognosis or the need for vasopressor medications.
* pregnant.