cyrilzakka/clinical-trials huggingface dataset:
The Impact of Denutrition on the Hospital Length of Stay for Patients Undergoing Rehabilitation

Denutrition is defined as a measurable decrease in functions and/or as change in the body composition, associated with a worsening of the prognosis of the underlying medico-surgical pathology. It is induced by a deficiency in energy, proteins or any other micro or macronutrient and is the result of malnutrition, itself caused by a poor diet or a metabolic disorder.

According to the National Nutrition and Health Plan for Belgium, denutrition is an independent risk factor for the increase of complications, morbidity and mortality rates, average length of hospitalisation and global medical care cost. It is necessary to invest in the prevention of denutrition as the costs of preventive measures are lower than the cost of treating a denutrished patient.

The Belgian financing system of hospitalisation days is based on the structure of the treated pathologies, the age of the patient and the geriatric features of the patient. It encourages all hospitals to lower the length of hospitalisation to the national average for all these criteria. As a consequence, there is a mounting tendency to shorten the average length of stay within the hospital.

The so-called 'Sp' hospital departments occupy a specific place within the organisation of Health Services in Belgium. They are specialized in the treatment and rehabilitation of patients with cardiopulmonary, neurological, locomotor, psycho-geriatric and chronic diseases. These services act as an extension of acute services (continuity of acute hospitalisation) but also as a first entry point for the medical care of patients with various specific diseases (multiple sclerosis, psycho-geriatric disorders, chronic pulmonary disorders...).

The financing of the Sp departments is, as opposed to the financing of other departments, not linked to the patient length of stay. However, an increase in hospitalization duration decreases the rate of admissions and the possibility to accept patients coming from acute hospital units.

The aim of the study is to evaluate the influence of denutrition of patients hospitalized in an Sp department on the length of revalidation stay, the associated costs and the patient's functional autonomy.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted within a revalidation unit of the CHU Brugmann hospital

Exclusion Criteria:

* Patients without programmed exit: transfer to another care unit, forced exit, death...
Identification of Predictive Factors for the Response to Anti-Programmed Cell Death Protein 1 (PD1) Immunotherapy in Head and Neck Squamous Cell Carcinoma

This project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC). This will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.

Tumor and blood samples will be collected on patients treated by anti-PD1 immunotherapy at different timepoints. Tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. Blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease
* Tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia
* Indication to treatment by anti-PD1 immunotherapy according to French competent authority recommendations
* Performance status 0, 1 or 2
* At least one measurable lesion on RECIST V1.1 criteria

Exclusion Criteria:

* Head and neck squamous cell carcinoma accessible to a local treatment
* Cancer of nasopharynx, sinus or nasal cavity
* Other histology than epidermoid
* Patients with contraindication for anti-PD1 immunotherapy
Evaluation Of Strategies For Improving Ketogenic Diet Compliance

In order to increase adherence to ketogenic diet treatment, palatability of meals and diversify the foods offered to patients a ketogenic kitchen will be created. Intervention: Incorporation of culinary workshops and supply of recipes for patients undergoing ketogenic diet treatment at Instituto da Criança - HCFMUSP.

Introduction: The ketogenic diet is a therapeutic option for the control of drug-resistant epileptic seizures. It is based on high fat consumption, protein control and carbohydrate restriction. As a result, the body uses fat as an energy substrate instead of glucose. Changing the patient's daily menu and eating routine is hard and requires dedication from the caregiver for the best therapeutic result. In clinical practice, the diet becomes monotonous and poorly accepted by the patient over time. Besides, there is a difficulty in understanding nutritional guidelines. It is necessary to develop strategies to increase adherence to treatment, palatability of meals and diversify the foods offered to patients. Objective: To evaluate the effectiveness of creating a ketogenic kitchen in improving compliance of patients with CD in the outpatient clinic of Instituto da Criança - HCFMUSP. Methods: this work will be carried out in 4 steps: (1st) Creation and validation of a questionnaire of ketogenic diet compliance, (2nd) Creation of ketogenic recipes of easy preparation and low cost, (3rd) Incorporation of culinary workshops and supply of recipes for patients undergoing treatment at Instituto da Criança - HCFMUSP and (4th) Application of the questionnaire of ketogenic diet compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients 0 to 18 years old;
* Clinical indication of a classic ketogenic diet;
* Predominantly oral feeding.

Exclusion Criteria:

* Patients using exclusive gastrostomy;
* Patients with other types of KD than Classical KD.
Use of Virtual Reality Game Playing During Venipuncture

To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.

Participants will be randomly assigned using a random number generator to either the virtual reality condition, or to the standard procedure that includes using books and/or watching movies as a standard method of distraction.

Participants will take part in the study during their scheduled research venipuncture. The venipuncture lasts approximately 15-30 minutes. Pre and post venipuncture questionnaires for both participant and parent will take 15 minutes to complete. Total study time is between 30 and 45 minutes. Questionnaires completed by research personal will take 15 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 8-19 years old that are receiving a blood draw as part of their ReCHARGE evaluation
2. History of distress or refusal of blood draws or similar medical procedures OR
3. Parent or child endorsement of fear, anxiety, concern or adherence in past blood draw during the recruitment phone call, consent or child evaluation will be offered the potential of the VR intervention OR
4. Endorsement of anxiety or concerns with medical procedures on an in house phlebotomist blood draw screening form will also be used as inclusion criteria.

Exclusion Criteria:

1. History of seizures.
2. Vision loss or significant visual impairment to the degree that the participant is unable to see the activity and features of the VR game.
Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis

The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function.

Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Bronchiolitis

Exclusion Criteria:

* Chronic disease
E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.

To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.


Eligibility Criteria:
Inclusion Criteria:

* all patients with suspected HAP undergoing BAL will be eligible

Exclusion Criteria:

* contraindications for BAL (PaO2/FIO2 \<100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria \<104 CFU/ml.
tDCS in Tourette (TIC-TDCS)

Double-blind randomized, sham-controlled clinical trial of 1 mA bilateral supplementary motor area in adolescents/adults with Tourette syndrome (TS). The primary objectives are to assess and quantify the safety and efficacy on tic severity of 5 inhibitory sessions of active vs. sham tDCS sessions during active tic suppression, and to explore the differences in brain functional activity before and after 5 sessions of active or sham cathodal tDCS in adolescents and adults with TS. Secondary objectives include the assessment of the severity of comorbidities after 5 inhibitory tDCS sessions.


Eligibility Criteria:
Inclusion Criteria:

* Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for TS (APA, DSM V).
* 16 years of age or older.
* A "moderately ill" or worse score on the Clinical Global Impression Severity scale (CGI-S).
* A total motor tic or vocal tic severity score greater or equal to 15/25 on the Yale Global Tic Severity Scale (YGTSS) or a combined score greater than 22/50.
* Participants should be either un-medicated or on stable medication treatment for tics for the previous 3 months. If receiving botulinum toxin treatment, their enrolment should be at least 16 weeks after the last treatment session.
* Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Have a metal object/implant in their brain, skull, scalp, or neck.
* Have an implantable device (e.g., cardiac pacemaker).
* Have a diagnosis of epilepsy or cardiac disease.
* Have a history of traumatic brain injury, learning disability or dyslexia.
* Have a severe impediment in vision or hearing.
The Application of the New Magnetic Resonance UTE Technique in Thoracic Lesions

Quantitative characteristic values of lung lesions were obtained by UTE technique, so as to make qualitative diagnosis of benign and malignant lesions. And to explore the clinical feasibility of CT-like technology - high resolution ZTE technology in the diagnosis of pulmonary diseases.

Ultrashort echo time (UTE) sequence can obtain data from T2\* for lung imaging before T2\* decays in lung parenchyma with extremely short echo time, which makes up for the defect that conventional MRI cannot clearly display short T2 tissue imaging, and can provide more supplementary information for lung CT scan. There has been a lot of research progress in the evaluation of neonatal lung disease, chronic obstructive airway disease and pneumonia. The 3D UTE sequence developed on this basis has made great progress in improving the resolution, signal-to-noise ratio and shortening the scanning time of lung MR Images, and has successfully obtained submillimeter high-resolution images. The purpose of this study was to explore the value of MRI ultra-short echo technology in the qualitative diagnosis of benign and malignant lung lesions, and to explore the clinical application of CT-like technology - high resolution ZTE technology in the lung.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. There are lung lesions, and the solid component is ≥6mm;
3. Chest CT plain scan or /+ enhanced examination within 4 weeks.

Exclusion Criteria:

1. There are metal implants in the corresponding parts of the chest;
2. MRI contrast agent allergy;
3. Claustrophobia;
4. Pregnant women;
5. High fever;
6. Respiratory failure;
7. Lung lesion biopsy within 4 weeks prior to examination.
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women

Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.

To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.

To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy women 45-60 years of age; 12 months amenorrhea
2. Documentation of \> 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
3. Availability of a family member or friend to drive participant home following clinic visits

Exclusion Criteria:

1. Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
2. Use of narcotics
3. Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
4. History of polycystic ovarian syndrome or hirsutism
5. Current history of depression
6. Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures
7. Substance abuse
8. Severe corn allergy
9. Known allergic reaction to pentazocine or naloxone
10. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
11. Hysterectomy
12. Use of anticholinergic medications
13. Lactating or pregnant
Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 to 45 years of age, inclusive, at screening.
* Absence of diseases that could affect the study outcomes.
* Having a body mass index (BMI) within normal standard limits (18.5 -24.9, inclusive) at screening.
* Females must have a negative serum pregnancy test at screening.
* Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.

Exclusion Criteria:

* History of bleeding tendency.
* Use of anticoagulant agent(s) within one (1) month prior to screening.
* Use of tobacco or nicotine products within six (6) months of screening.
* Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
* On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
* History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within one (1) year prior to screening.
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening.
* Pregnant or breast feeding.
* Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:

  1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40IU/L, OR;
  2. Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
  3. Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation.
* Known or suspected hypersensitivity to any ingredient of the study drug(s).
* Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.
The Efficacy, Safety, and Immunogenicity Study Comparing an Insulin Glargine Biosimilar Sansulin Log-G to Lantus

This is an open-label randomised multicenter clinical study to investigate efficacy, safety, and immunogenicity of the drug products: Insulin Glargine biosimilar ® Log-G and its reference Lantus® in type 2 diabetes mellitus patients

Sansulin® Log-G is an insulin glargine biosimilar. For a biosimilar, its efficacy, safety, and immunogenicity should be compared head-to-head with its reference product in at least non-inferiority study. Immunogenicity assessment should always be done because it is influenced by so many factors, from nature of the drug substance until patient and disease related factors. Moreover its consequences also vary considerably, from clinically irrelevant to serious and life-threatening. Immunogenicity of a biosimilar should always be investigated in humans, since animal data are usually not predictive of the immune response in humans.

Since blinding of study participants is likely unfeasible, at least anti-drug antibodies should be determined in a blinded fashion. Since anti-insulin antibodies develop early, then 6 months duration of study is adequate.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with DM type 2, age at least 18 years, both genders.
2. T2DM patients who have been diagnosed for \> 1 year, and have been treated with one oral antidiabetic at stable doses for \> 3 months prior to screening, have BMI of 18.0 to 35.0 kg/m2 inclusive, and HbA1C of \> 7.0% and insulin-naive.
3. Patients who are cooperative, reliable, and agree to have regular injections of insulin, and are willing to comply with protocol procedure (willing to sign the informed consent).
4. Female patients with adequate protection from conception. Females of childbearing potential must use a reliable method of birth control during the study (barrier-method or IUD). Women with history of bilateral tubal ligation, or with total hysterectomy, or who are 2 years postmenopausal are also eligible.

Exclusion Criteria:

1. Pregnancy (confirmed by a positive urine pregnancy test) or lactation.
2. History of severe hypoglycemia during the last year (blood glucose level \<50 mg/dl with transient dysfunction of central nervous system without other apparent cause)
3. History of diabetic ketoacidosis \> 2x within the last year.
4. Having hyperglycemia hyperosmolar status (HHS)
5. Renal impairment (eGFR \< 30 mL/min).
6. An employee of the Investigator or the Sponsor.
7. Participating in another clinical study within the past 3 months.
8. Receiving any immunosuppressants, including corticosteroids or cytostatics within the last year or during the study.
9. Receiving any drug or supplement with hypoglycemic activity (except oral antidiabetics) within 4 weeks prior to screening and during the study.
10. Receiving any drug with hyperglycemic activity within 4 weeks prior to screening and during the study (eg. second generation antipsychotics, corticosteroids, tacrolimus, protease inhibitors).
11. Have undergone pancreatectomy or pancreas / islet cell transplant.
12. Mental disorder
13. Any malignancies
A Study to Evaluate the Safety of Empliciti® (Elotuzumab) When Treating Patients With Multiple Myeloma in Taiwan

This observational study aimed to assess the safety of elotuzumab when used in combination with pomalidomide and dexamethasone for the treatment of relapsed and refractory multiple myeloma (RRMM) in participants who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The study will also assess the safety of elotuzumab when used in combination with lenalidomide and dexamethasone in RRMM participants who had received one to three prior therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed diagnosis of RRMM
* Received ≥ 2 prior therapies including lenalidomide and a proteasome inhibitor
* Planning to receive elotuzumab in combination with pomalidomide and dexamethasone at physician's medical judgement OR
* Age ≥ 18 years
* Confirmed diagnosis of RRMM
* Received one to three prior therapies
* Planning to receive elotuzumab in combination with lenalidomide and dexamethasone at physician's medical judgement

Exclusion Criteria:

* Participants with therapeutic indications for which elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone has not been approved in Taiwan
* Participants who are contraindicated for treated with elotuzumab in combination with pomalidomide/lenalidomide and dexamethasone (as described in the Taiwan label)
* Participants who participate in other interventional clinical trials