cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids.

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after transplantation.

Eligibility Criteria:
Inclusion criteria:

* At least 18 years of age
* End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
* Patients with a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

* Planned antibody induction
* Multiple organ transplants
* History of malignancy within five years of enrollment
Pistachios Blood Sugar Control, Heart and Gut Health

A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.

A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25 and ≤45 kg/m2
* Fasting plasma glucose 100 - 125 mg/dL
* non-Smoking

Exclusion Criteria:

* Diagnosed diabetes or fasting glucose \>126 mg/dl
* Systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
* Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
* Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
* Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* Smoking or use of any tobacco products
* Allergy/intolerance/sensitive to pistachios
* Consumption of \>14 alcoholic drinks/week
* Shift-workers and those who cannot consume a snack in the evening
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject, of any race, who is at least 1 year of age.
* Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye.
* The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less.
* Must be willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria:

* Any uncontrolled, systemic, debilitating disease.
* Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study.
* Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study.
* Any active upper respiratory tract infection.
* Pregnant or nursing females.
* Use of any antibiotic (topical or systemic) within 72 hours of enrollment
Postural Drainage and PEP Technique in Community Acquired Pneumonia

Community-acquired pneumonia is acquired outside the hospital. Postural drainage is the positioning of a patient with an involved lung segment such that gravity has a maximal effect of facilitating the drainage of Broncho-pulmonary secretions from the tracheobronchial tree. It is based on the concept of gravity-assisted mobilization of secretions and transports it for removal. The objective of the study to find the effect of postural drainage and positive expiratory pressure techniques (PEP) to improve the air way clearance and breathing in pneumonia patients. This study will be a RCT and will be conducted in Services Hospital. The study will be completed within the duration of six month. Consecutive sampling study technique will be used to collect the data. The sample size of 46 patients will be taken. Patients will be divided into two groups. (Group A will be treated with postural drainage and Group B will be treated with positive expiratory pressure technique). Outcome measure will be taken on Pulse oximeter, incentive spirometer and chest X- Ray. A regular follow up visits to department and a final assessment was made at the end of four week. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro- Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with community acquired pneumonia.
* Clinically stable patients.
* Both genders
* Age 30 to 70 years

Exclusion Criteria:

* Presence of any genetic disorders (cystic fibrosis).
* Recent spinal / chest surgery
* Cardiac issues
* Fractures of vertebra caused by osteoporosis.
Investigation of How Morning Nutrition Influences Cognitive Performance

This project will assess the effects of the macro-nutrient make-up of morning food intake on cognitive performance using visual analog scale (VAS) measures, behavioral tests, and advanced high-density electrophysiological techniques (256-channel recordings). Two Isocaloric cereal products will be tested and compared to determine if measures of cognitive performance as well as satiety will change after consumption.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and taking no regular medications other than birth control or hormone replacement therapy
* Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children
* Willing and able to sign informed consent
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing
* No history of neurological or psychiatric illness, including major depressive disorder and attention deficit disorder
* No history of substance, nicotine or alcohol dependence
* BMI below 35

Exclusion Criteria:

* Women who are pregnant or nursing
* Gain or loss of \> 4kg in the last 3 months.
* Currently taking supplements or medications for weight loss
* Currently taking medications for neurological or psychiatric illness
* Diabetes mellitus (fasting glucose \>126 mg/dL) or history of diabetes
* Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
* Allergy to any of the foods used for the test breakfasts (oats or milk)
* History of GI disorders or GI surgical procedures for weight loss
* History of eating disorders
* Daily consumption of more than 400 mg of caffeine
Hematological Anomalies in Children With Rasopathy

During childhood, patients with RASopathies (Noonan syndrome and related diseases) can harbor various hematological anomalies ranging from isolated monocytosis, myelemia, thrombocytopenia or splenomegaly to myeloproliferative disorders. These anomalies may spontaneously disappear or persist, sometimes leading to juvenile myelomonocytic leukemia. Guidelines for initial screening and subsequent hematological follow-up have recently been published in France: peripheral blood analysis should be performed in all newly diagnosed patients and followed by biannual peripheral blood analysis in infants until the age of 2 years.

In order to describe the characteristics of these abnormalities in terms of their incidence, age of occurrence, evolution and relation to genotype, we are conducting a longitudinal prospective study whose aim is to analyze peripheral blood cell counts and smears at diagnosis and one year later. In patients \<3 years of age recruited at certain centers, biobanking of mononuclear cells will be performed. These data could yield a new insight into hematological anomalies in patients with RASopathies and thereby help physicians to determine the appropriate rhythm for hematological follow-up according to genotype.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 16 years
* Patient newly diagnosed with genetically confirmed rasopathy : Noonan syndrome, type 1 neurofibromatosis, Noonan syndrome with multiple lentigines, CBL syndrome, Costello syndrome, cardiofaciocutaneous syndrome or Legius syndrome i.e. with a germline mutation of one of these genes: PTPN11, SOS1, NRAS, RAF1, BRAF, SHOC2, MEK1, MEK2, CBL, NF1, SPRED1, KRAS, HRAS, NF1, SHOC2, LZTR1, SOS2, RIT1, RASA2, RRAS, PPP1CB, or a new gene of interest published during the recruitment period
* No history of hematological malignancy
* Written informed consent obtained from the parents
* Health insurance

Exclusion Criteria:

* History of malignant hematological pathology
Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and over.
* Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
* Injury within past 12 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.
* During the past 3 months: Grade I-III sprain of the same ankle.
* During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
* Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
* Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Simulation Training of Closed-Loop Communication (CLC)

Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training.

Closed-Loop Communication (CLC) is a proposed, taught and practiced Crisis Resource Management (CRM) strategy thought to be effective for enhancing patient safety by enforcing reiteration and clarity, thus reducing ambiguity during verbal communication among health care providers. The transfer of this CRM strategy into clinical practice seems to require recurring exposure. Teaching and training is needed to help health care providers develop routine in communicating. This training is most effective if practiced in the clinical setting that is familiar to the health care provider (in situ simulation). As trainees become more proficient, the ultimate goal is to integrate Closed-Loop Communication into daily habits of verbal interaction in every health care setting. One way to practice the utilization of Closed-Loop Communication is simulation. The investigators seek to investigate if simulation participants can incorporate CRM strategies such as Closed-Loop Communication into their communication repertoire. This shall serve as an example of attitude transfer following a simulation based learning experience.The primary study objective is to measure the success of simulation training for increasing Closed-Loop Communication as a behavioural change in the clinical setting.

Eligibility Criteria:
Inclusion criteria:

* Employees, with written informed consent, working in the paediatric intensive care unit of the Children's Bern University Hospital
* Employees novices to in-situ simulation

Exclusion criteria:

* employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are not fluent in German or Swiss German.
* employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are unable to be observed during phases I and II and during the follow up phase (see below).
* No vulnerable participants will be included.
Efficacy and Safety With Ziprasidone in First-episode Psychosis

The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder

Exclusion Criteria:

* Patients with previously prescribed antipsychotic medication in 2 weeks or more
* patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
Educational Program for Ostomy Patients (Ostomeducat)

Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the introduction of an outpatient preoperative stoma education program.

38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Exclusion Criteria:

* Patients already had a stoma before the operation or in case of emergent surgery.
Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.

Will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.

The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation.

Two A and B study groups of paraplegic subjects will be built-up in a randomized way. Under standardized conditions, the A study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. Under the same conditions but without the developed device, the B study group subject will have an usual behavior.

The analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer.

Eligibility Criteria:
Inclusion Criteria:

* patient affiliated to social security or similarly regime
* paraplegic medullary patient
* more or equal than 18 years old.

Exclusion Criteria:

patients will be excluded if at least one of the following criteria is present :

* pregnancy and feeding women
* persons without liberty by administrative or judiciary decision
* persons hospitalized without consent
* persons concerned by a justice protection action
* dependant major person
* palatine prosthesis intolerance
* buttock pressure ulcer evolution
* acute pathology (particularly mouth level)
* nickel allergy
* impossibility to use the medical device, to understand or realize the protocol due to cognitive pathologies.
* patient with dental troubles incompatible with the realisation or utilisation of orthodontic prothesis.
* no tactile feeling with tongue,
* impossibility to set up the orthodontic prothesis due to superior limb deterioration
68Ga-P16-093 PET/CT Imaging in Glioma Patients

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including glioma. This makes it a potentially imaging target for the detection and grading of gliomas. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with MRI in the same group of glioma patients.

Glioma is the most common primary malignant brain tumor which can be divided into four grades according to different histopathological and molecular biological characteristics.Among them, glioblastoma is one of the most common types of glioma in adults (about 55%). It belongs to WHO Grade IV high-grade glioma, with a high recurrence rate, poor prognosis, and a 5-year survival rate of less than 10%. Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as glioma. Therefore, PSMA may be an ideal target for the diagnosis of glioma. 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in the same group of glioma patients, compared with MRI.

Eligibility Criteria:
Inclusion Criteria:

* glioma patients highly suggested by MRI or histologically confirmed;
* 68Ga-P16-093 PET/CT and MRI within two weeks;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Low Versus High-intensity Exercises in Sarcopenia

this study aims to compare the effect of high-intensity resistance exercises measured using the 10-repetition maximum versus low-intensity aerobic exercises on muscle performance, physical function and quality of life in chronic kidney patients with sarcopenia who recently recovered from COVID-19 infection

Sarcopenia is a prevalent chronic disease caused by aging and is characterized by a reduction in muscle strength and mass (Barajas-Galindo et al., 2021), and consequently deterioration in physical function and quality of life (Gil et al., 2021; Tsekoura et al., 2017). Sarcopenia is associated with higher rates of stroke, frailty, (Bikbov et al., 2020; Go et al., 2004; Levin et al., 2013), and mortality (Ali \& Kunugi, 2021). Generally, there are numerous causes of sarcopenia, including chronic kidney diseases (CKD) (Souza et al., 2017), environmental factors, inflammatory mediator's activation, physical inactivity, mitochondrial dysfunction, hormonal changes, and loss of neural junctions (Walston, 2012).

Recently, Sarcopenia had great attention, especially among patients with CKD who already suffer from increased catabolism, higher protein wasting, and other metabolic disorders and decreased functional reserve. Additionality, the decline in physical function due to the deterioration of muscle mass, power, and strength could significantly decrease balance and increase the risk of falling in these populations (Moorthi \& Avin, 2017).

After the pandemic of COVID-19 and the mandatory quarantine of patients during the recovery period, CKD patients with sarcopenia who were infected with COVID-19 will be forced to assume a more sedentary lifestyle which consequently magnifies all health risks (Gérard et al., 2021; Gil et al., 2021) jeopardize subjects vitality (Morley et al., 2020; Mousa et al., 2021) and increasing prevalence of sarcopenia (Ali \& Kunugi, 2021).

Exercise has been proposed as one of the solutions for sarcopenia-associated symptoms. As per a recent systematic review (Barajas-Galindo et al., 2021), resistance exercises alone or with other forms of exercises could be beneficial especially in improving anthropometric parameters and muscle performance. Yet its specific effects on post-COVID-19 CKD patients who have sarcopenia need further investigation.

The aim of this study is to compare the effectiveness of high versus low-intensity exercises on muscle strength, and physical function in post-COVID-19 patients with sarcopenia secondary to CKD.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes with age between 50 - 70 years old.
* CKD stages (3 and 4)
* Infected by COVID-19 and recovered (1 - 2 months)
* Score of 4 or more on SAR-QoL Questionnaire
* Patients having had a medical prescription for physical rehabilitation.

Exclusion Criteria:

* Patients infected again by -CoVID-19
* Any serious inflammatory, neurological, or cardiovascular diseases.
* Chronic chest disease.
* Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
* Mental impairments.
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a diagnosis of plaque-type psoriasis for at least 6 months.

Exclusion Criteria:

* Patients with hypersensitivity to ustekinumab or any of the product excipients.