cyrilzakka/clinical-trials huggingface dataset:
Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children

The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Eligibility Criteria:
Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the designated childcare centers

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who will not be present at the childcare center for all of the scheduled study days
Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study

The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the central nervous system (CNS). The MS disease is characterised by recurrent transient disability progression, quantified by increase in the extended disability status score (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or, alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms. At the same time, the MS is characterised by multifocal inflammatory lesions disseminated throughout the white and grey matter of the CNS, which can be observed and quantified in the magnetic resonance (MR) scans. The proposed study will address the critical unmet need of computer-assisted extraction and assessment of prognostic factors based from an individual patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized future disability progression prediction.


Eligibility Criteria:
Inclusion Criteria:

* persons diagnosed with MS (any phenotype; according to the 2010 McDonald criteria) and CIS patients
* availability of at least two MRI exams with both FLAIR and T1-weighted scans of the same participant over a period of at least 6 months at the most recent examination
* availability of demographic, clinical data and treatment information for the same participant over a period of at least 6 months at the most recent examination
* availability of EDSS score and at least one previous EDSS scores for the same participant over a period of at least 6 months at the most recent examination

Exclusion Criteria:

* other clinically relevant systemic diseases if the researcher considers them to be significant
Effects of Prehabilitation and Early Mobilization for Patients Undergoing Pancreas Surgery.

Open upper gastrointestinal surgery includes surgery in the upper abdomen such as ventricular, duodenal, pancreatic and biliary tract surgery. After upper abdominal surgery there is a risk of gastrointestinal and cardiopulmonary complications. There is currently insufficient knowledge about the effect of prehabilitation and extra early postoperative mobilization in upper pancreatic surgery.

This study's aim is to evaluate the effect of prehabilitation and extra early mobilization.

The study includes two substudies:

1. A prospective cohort of 75 patients undergoing pancreatic surgery after a prehabilitation program will be compared to 75 historical controls. Primary outcome is postoperative complications.
2. A randomized controlled trial based on 72 patients undergoing pancreatic studying the effect of extra early rehabilitation. The intervention group will be mobilized to bedside, standing or sitting in armchair \<6 hours after surgery, ie 3-4 hours after arrival at the Postoperative Department (PIVA). The control group will be mobilized according to routine i.e. the morning after surgery. Primary outcome is PaO2.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo pancreatic surgery

Exclusion Criteria in substudy b:

* Preoperative injury or disease making it impossible to perform the intervention
Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T

Inclusion visit (D0):

* verification of inclusion and non-inclusion criteria
* information and collection of consent
* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
* 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* To benefit from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation of inflammatory involvement of the nevrax
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant, parturient or breastfeeding woman
* Absolute or relative contraindication to MRI
A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132

The purpose of this study is to allow the continued administration of Deucravacitinib in participants with Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) who have completed study IM011074 or Study IM011132


Eligibility Criteria:
Inclusion Criteria

* Participants must have completed Study IM011074 or Study IM011132 through the protocol-required treatment period.
* Participants must be, based on the physician's medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.
* Participants must have received IP within 60 days of enrollment. Exceptions may be granted based upon consultation with BMS.

Exclusion Criteria

* Participants must not have any disease or medical condition that, in the opinion of the physician, would make the subject unsuitable for this protocol, would interfere with the interpretation of subject safety or considered unsuitable by the physician for any other reason.
* Participants must not have any evidence of active Tuberculosis (TB).
* Other protocol-defined Inclusion/Exclusion criteria apply.
Early Continuous Renal Replacement Therapies (CRRT) in Patients With Severe Sepsis or Septic Shock With Acute Kidney Injury

Severe sepsis or septic shock with acute kidney injury shows high mortality in intensive care unit. A few studies have shown CRRT relating the clinical improvement seems to be related to the early initiation of therapy. But there is no consensus for proper time of CRRT may improve the prognosis.

The study is a prospective randomized one center trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU, treated either early by CRRT (35 ml/kg/h) or by conventional RRT.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock (Bone criteria) for less than 14D
* RIFLE criteria : Injury or Failure or nearly anuria more than 2hr
* Age over 18 years
* Written informed consent by next of kin.

Exclusion Criteria:

* Cirrhosis child class C
* CRF or ESRD
* Too high APACHE II \& SOFA score at admission
* Age over 80 years
* Life expectancy less than 3 months (metastatic cancer - hepatoma, lung ca.)
Peritoneal Dialysis Versus Haemodialysis

Study in order to quantify toxin removal during dialysis


Eligibility Criteria:
Inclusion Criteria:

* Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
* Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
* Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).
Staphylococcus Aureus Decolonization Study

The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.

Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).

CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts.

Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.

Eligibility Criteria:
Inclusion Criteria:

Screening:

* Children aged 6 months to 21 years presenting with an active skin or soft tissue infection.

Enrollment:

* Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).

Exclusion Criteria:

* Infants less than 6 months of age
* Dialysis or residence in a long term care facility over the past year
* Use of chlorhexidine or mupirocin in the past one month
* Pregnancy
* Immunodeficiency
* History of an adverse reaction to chlorhexidine or mupirocin.
Local Anesthetic Concentration and Nerve Block Duration

Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass.

Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers.

Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose.

Primary endpoint: Sensory nerve block defined by insensitivity towards cold.

Background:

Important factors for a safe and successful nerve block include volume, dose and concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve block techniques it has been possible to substantially reduce the amount of LA required to perform a successful nerve block. This has reduced the risk of systemic toxicity. However, lowering LA volume may reduce nerve block duration, but the extent of this is sparsely described in a heterogenic study mass.

Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore, increasing LA concentration seems to increase the level of motor block, but not the block duration. A long-lasting nerve block without dense motor block is preferable for optimized pain control and better opportunities to rehabilitate/ambulate.

Aim:

To investigate the effect of LA concentration on common peroneal nerve block duration in healthy volunteers.

Methods:

Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose (10mg).

Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.

Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.

Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and motor nerve block; Length of neural exposure to LA.

Eligibility Criteria:
Inclusion criteria

1. Male or female from and above 18 years of age
2. ASA classification ≤ II

Exclusion criteria

1. BMI below 18 kg/m2
2. Former surgery to the lower extremity in which intervention is planned and surgery which may have caused neural damage to the common peroneal nerve/affected the sensory distribution area of the common peroneal nerve
3. Peripheral nerve disease
4. Allergy to LA
5. Pregnancy or breastfeeding
6. Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
7. Habitual use of any kind of analgesic treatment
8. Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion
Lidocaine as Local Anesthetics in Children Under Ketamine Sedation

Ketamine seems an obvious choice in the setting of an emergency department in laceration repair.

Lidocaine is the local anesthetics widespread used.

Ketamine leads to dissociative amnesia.

Theoretically , lidocaine is not useful in laceration repair using ketamine.

However, lidocaine is used with ketamine in many emergency department.

The investigators compare lidocaine with placebo as an adjunct to ketamine sedation in children undergoing primary closure


Eligibility Criteria:
Inclusion Criteria:

* patients who need suturing for laceration under procedural anesthesia using ketamine

Exclusion Criteria:

* contraindication to ketamine and lidocaine
* patients involved to other studies
* more or equal to American Society of Anesthesiologist (ASA) class III
* not alert
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).

The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). Our hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at Day 7 and Day 14 compared to Baseline.

Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. Our hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at Day 7 and Day 14 compared to Baseline. Other secondary outcome measures include Eczema Area and Severity Index (EASI) score, body surface area involvement and Visual Analog Scale for itch. The investigators hypothesize that each of these measures will be improved at Day 7 and Day 14 compared to Baseline.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
* Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
* Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
* Percentage of overall body surface area of involvement (BSA) must be ≥2%.
* Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.

Exclusion Criteria:

* Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
* Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
* Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
* Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
* Amount of disease involvement that would require \>60 gm of cream in a 1 week period.
* Subjects with known allergy or sensitivity to topical Vanos® cream or components.
* Pregnant women
* Women who are breastfeeding
An Observational Study Looking at How Well the Drug Eligard Works and How Well it is Tolerated by the Body of Patients With Advanced Prostate Carcinoma in the Russian Federation

Eligard is a 6-month depot injection formulation that combines the active ingredient leuprorelin acetate (LA) with a biodegradable polymer matrix (Atrigel® delivery system). The 6-month (45 mg) formulation was approved for the Russian market in 2009. It has been shown to reduce testosterone and prostate-specific antigen (PSA) levels and to be well tolerated in several clinical trials. However, clinical trials are limited by strict patient inclusion and exclusion criteria. Therefore, the current non-interventional study aimed at investigating whether the efficacy and tolerability of the 6-month LA depot formulation could also be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.

This study will evaluate total serum PSA and testosterone levels, Quality of Life (QoL) of patients, demographic patient data, diagnosis and diagnostic findings in patients. It will provide analysis in different subgroups of patients depending on previous hormonal treatment and anamnesis of disease.


Eligibility Criteria:
Inclusion Criteria:

* All male patients \> 18 years of age with advanced PCa to whom oncourologist decided to prescribe Eligard 45 mg

Exclusion Criteria:

* Patient participation in any clinical trials.
Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF

To solve the existing Knee osteoarthritis;KOA) clinical norms and guidelines have low operability, Disconnection between treatment plan and specific evaluation results, difficulty in achieving individualized intervention and other problems, on the one hand, we need to develop Chinese expert consensus or clinical path based on evidence-based medicine to adapt to China's national conditions, on the other hand, is more important in The KOA clinical process introduces a set of tools to translate evidence-based medicine evidence into specific, actionable treatments, Thus, a more flexible, more comprehensive and three-dimensional, adaptable, targeted, more conducive to the promotion of the individual integration KOA rehabilitation intervention program.


Eligibility Criteria:
Inclusion Criteria:

* Neither knee had undergone knee replacement, and no knee replacement had been performed in recent half a year planning to have a knee replacement; Volunteered to participate in the study and signed the informed consent.

Exclusion Criteria:

* People with consciousness disorder, cognitive disorder, severe mental illness, unable to accurately express their own will, or unable to cooperate with the completion of various assessments and treatment
A Clinical Trial to Evaluate the Safety and Efficacy of Olanzapine Titration Schedule in Patients With Schizophrenia

The objective of this clinical trial is to evaluate the safety and efficacy of olanzapine titration schedule in patients with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Of patients with schizophrenia in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria, who are judged that administration of low dose is more appropriate than initial recommended dose or standard titration dose of olanzapine to consider medical conditions by investigator
* Patients with the duration of schizophrenia for more than 1 year at screening visit(Visit 1)

Exclusion Criteria:

* Patients diagnosed schizophrenia spectrum and other psychotic disorder(e.g. schizoaffective disorder, etc.), bipolar disorder, depressive disorder, etc., in accordance with DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 diagnostic criteria at screening visit(Visit 1)
* Patients with a history of hospitalization for worsening schizophrenia within 12 weeks at screening visit(Visit 1)
Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis

The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.


Eligibility Criteria:
Inclusion Criteria:

* Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
* ≥ 18 years old.

Exclusion Criteria:

* History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
* Current or prior history of alcohol or drug abuse (illicit or prescription)
* History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
* History of cardiac arrhythmia or untreated severe cardiovascular disease
* Uncontrolled hypertension
* Hepatic insufficiency
* Renal insufficiency (CKD stage IIIa or greater)
* Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement
* Poorly controlled diabetes mellitus (defined as HgbA1c \> 8.5 within 30 days of surgery)
* Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting)
* Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.)
* Planned infrapubic or subcoronal incision at the time of penile prosthesis placement
* Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia)
* Allergy or history of intolerance to any local anesthetic agents included in the protocol
* History of prior penile prosthesis or artificial urinary sphincter surgery
* Revision penile prosthesis surgery