cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of CYT004-MelQbG10 Vaccine With and Without Adjuvant in Advanced Stage Melanoma Patients

The purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a Melan-A VLP vaccine alone or in combination with different adjuvants.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed Stage III or IV malignant melanoma
* HLA-A\*0201 haplotype
* Expected survival of at least 9 months
* Willing and able to comply with all trial requirements (e.g. diaries, CTs)
* Given written informed consent
* Females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception

Exclusion Criteria:

* Any contraindication to any study related test or assessment
* Current or planned use of contraindicated concomitant medication
* Presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease
* Infection with HIV, HBV or HCV
* Pregnancy or lactation or females planning to become pregnant during the study
* Abuse of alcohol or other drugs
* Use of investigational drug within 30 days before enrolment
* Previous participation in a clinical trial with a Qb-based Cytos vaccine.
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

The purpose of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB5 and Humira (EU sourced Humira® and US sourced Humira®) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Have a body mass index between 20.0 and 29.9 kg/m², inclusive.

Exclusion Criteria:

* History and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference investigational product formulation or comparable drugs
* Active or latent Tuberculosis or who have a history of Tuberculosis
* History of invasive systemic fungal infections or other opportunistic infections
* Systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
* Serious infection associated with hospitalisation and/or which required intravenous antibiotics
* History of and/or current cardiac disease
* Have received live vaccine(s) within 4 weeks prior to Screening or who will require live vaccine(s) between Screening and the final study visit
* Intake medication with a half-life \> 24 h within 4 weeks or 10 half-lives of the medication prior to investigational product administration
The Relationship Between Physical Activity Level and Reaction Time in University Students

Reaction time, movement and total movement time are said to affect athletic performance.

The unit of time between giving a stimulus to the person and the beginning of the person's voluntary response to this stimulus is defined as the reaction time.

Recent studies have reported that reaction time may depend on gender differences, neuromuscular and neurophysiological factors, force production, structural and neural properties of muscles, and information processing speed.

In recent studies, it has been reported that reaction time can be affected by parameters such as gender, neuromuscular and neurophysiological factors, force production, structural and neural properties of muscles, and information processing speed. Reaction time measurements are basically for two functions. The first of these is the situations that we encounter during traffic lights, sportive activities or daily life activities. The other is to measure the duration of mental activities such as processing the stimulus from the environment, making decisions, programming the reaction.

Physical activity is defined as all movements that require energy expenditure as a result of the use of skeletal muscles. Physical activity has positive effects on the development of muscle strength, balance, flexibility, posture, reaction time and motor skills. There is a complex relationship between physical activity and cognitive performance. Depending on the chosen cognitive task and the type of exercise, there is a change in cognitive load.

Eligibility Criteria:
Inclusion criteria;

* Being between the ages of 20 - 30,
* Healthy individuals,
* Absence of carpal tunnel syndrome, Exclusion criteria ;
* Not having a musculosketal or neurological disease that limits mobility
* Absence of upper extremity sequelae,
Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.

During fasting the human body is known to metabolize relatively large amounts of fat, in the expense of proteins and glucose. Partly this shift in metabolism is caused by increasing GH secretion, but exactly how growth hormone exerts these effects remains to be further investigated.

10 healthy lean young men are studied at 4 different occasions in a randomized single-blinded cross-over study. 1: after 12 hours of fasting + GH bolus, 2: after 36 hours of fasting + GH bolus, 3: after 36 hours + saline, 4: after 36 hours of fasting + Somavert.

Aim:

* to study the signal transduction in muscle and fat tissue
* to study the metabolism during fasting
* to study the intrahepatic fat content using magnetic resonance techniques

Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* age 20 - 40 years of age
* BMI 20 -25

Exclusion Criteria:

* uses any medication
* drinks more than 21 units of alcohol per
* is claustrophobic
* carries any magnetic devices
Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 years of ag.
* Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
* The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100.4°F, axillary temperature \>38.1°C/100.6°F, tympanic temperature \>38.5°C/ 101.2°F, or a rectal/core temperature \>39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95°

Exclusion Criteria:

* Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days)
* Hospitalization within 14 days prior to the onset of symptoms
* Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms
Impact of a Neonatal-Bereavement-Support DVD on Grief

Experts agree that neonatal death has long-term impact on parents. Many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. There are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. The purpose of this study is to evaluate the impact of a neonatal intensive care unit (NICU) bereavement support program and the use of a newly designed family-centered bereavement DVD. This educational DVD includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the NICU.

The care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process. For many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond. It is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations. However, supporting families following the death of an infant is particularly challenging. There is limited bereavement intervention guidance in the literature that may benefit grieving parents. Follow-up care is a crucial part of bereavement management of families whose babies have died. The bereavement committee at St. Louis Children's Hospital (SLCH) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents. Their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital. In addition to receiving bereavement materials, which is considered standard-practice of care in the NICU at SLCH following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Any parent who has experienced the death of a baby in the NICU at SLCH or has had a baby treated in the NICU who has died at home with hospice care

Exclusion Criteria:

* Babies who are at home longer than one month with hospice care will be excluded
* Those who are not English speaking or who are illiterate
Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.

In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of gamma globulin therapy in patients with severe infection including sepsis and septic shock is discussed controversially. We intend to retrospectively analyze the efficacy and application evaluation of gamma globulin in severely infected children hospitalized in the intensive care unit. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. It is expected to provide evaluation basis for clinicians to formulate treatment plans and clinical pharmacists for special comments on the clinical use of gamma globulin.

Eligibility Criteria:
Inclusion Criteria:

* children hospitalized in PICU of Children's Hospital of Fudan University
* Children With Severe Infection Complicated With Inflammatory Storm

Exclusion Criteria:

* discharge within 48 hours
* patients without informed consent
* incomplete clinical and demographic data
Cervical Arthroplasty "Fixed Core" Versus "Movable Core": Clinical and Radiological Impact in the Medium Term

Nowadays, there is no clinical and radiological study comparing two different types of mobile implants in patients requiring surgical treatment for symptomatic cervical disc disease. Thus, the choice of the ideal implant remains uncertain.

The goal of this work is to compare the impact of two types of mobile implants in height drives, solicitation facets, positioning and collection of prostheses within the intervertebral spaces.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Symptomatic cervical disc degenerative pathologies to 1 or more contiguous or non-contiguous levels C3-4 to C6-7.
* Symptoms including: Cervicobrachial neuralgia and / or Loss of root muscle strength and / or Sensory impairment and paresthesia and / or Cervical myelopathy table
* Concordant diagnosis confirmed by CT (Computerized Tomography scanner) and MRI (Magnetic Resonance Imaging) of the cervical spine
* NPDS (Neck Pain and Disability Scale) \> 30
* Failure to respond to conservative medical treatment for 6 weeks or worsening symptoms despite conservative treatment
* Physical and mental fitness to ensure compliance with the protocol
* Signed informed consent

Exclusion Criteria:

* Unstable cervical spine injuries requiring fusion C1 to C7 for whatever the etiology, proven on dynamic views of the cervical spine
* Paget's disease, osteomalacia, other metabolic bone diseases
* Chronic corticosteroid use
* Active tumor pathology
* Segmental angulation \< -11 ° or \> 11 ° at the respective segment or adjacent segments on static images of the cervical spine
* Known allergy to Chromium, Cobalt, Mobdylene (chemical element), Polyethylene, or Titanium
* History of surgery in the previous 30 days before inclusion
* History of mental illness or disability involving a "safeguard procedure justice of the person"
* Contraindications to non steroidal anti inflammatory
Transcranial Galvanic Stimulation After Stroke

Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.


Eligibility Criteria:
Inclusion Criteria:

* subacute stroke
* stroke interval 3 to 8 weeks
* severe upper limb paresis
* Fugl-Meyer \< 18

Exclusion Criteria:

* history of epilepsy
* antiepileptic, neuroleptic medication
* metal implants
Conjunctival Flora Before Cataract Surgery: a Microbiological Evaluation

The purpose of the present study is to elucidate the qualitative and quantitative variation of ocular flora after treatment with eyedrops containing 0.6% povidone-iodine in the eye of patients undergoing routine cataract surgery.

Two conjunctival swabs will be executed at 3 days before and at the day of routine cataract surgery in each eye of patients undergoing routine cataract surgery. After the collection of the first conjunctival swab a three-days treatment with eyedrops containing 0.6% povidone-iodine in the eye undergoing routine cataract surgery will be performed. Bacterial isolates will be identified by using standard microbiological protocols and total bacterial load will be determined at the two different time points. In vitro susceptibility testing to determine methicillin resistance in isolated Staphylococcus species will be performed. Controlateral eye of each patient will be used as control. Descriptive statistics will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Males and females aged between 40 and 80 years
* Patients who are candidates for cataract extraction

Exclusion Criteria:

* Males and females under 40 years and over 80 years
* Previous diseases of the eye, ocular surface and thyroid disease
* Known hypersensitivity to the product
* Presence of autoimmune diseases
* Pregnancy or breast-feeding
* Participation in other clinical studies
In Vivo Succinate Detection After External Beam Radiation Therapy in SDHx- Paragangliomas

Qualitative and quantitative biomarker of response to radiotherapy is needed in paragangliomas. We aim at assessing the added value of 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

Paragangliomas (PGL) are rare neuroendocrine tumors inherited in 40% of cases. SDHx genes (SDHA, SDHB, SDHC, SDHD), encoding the 4 subunits of the mitochondrial enzyme succinate dehydrogenase (SDH), are the most frequently involved.

Accumulation of succinate, the substrate for SDH, is a very specific biomarker for these mutations. Recently, we have demonstrated the feasability of detecting and quantifying succinate in tumors in vivo, by magnetic resonance spectroscopy (1H-SRM).

Patients carrying these mutations frequently develop cervical PGL for which the treatment of choice is external beam radiation therapy (EBR).

The objective of this project is to determine the feasibility of using 1H-SRM for the evaluation of early response to EBR therapy in patients with cervical SDHx PGL.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Signed informed consent
* Patient with cervical PGL with planning of treatment with EBR
* Patient with an SDHx mutation or unknown genetic status
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman
* Contraindication to MRI (implantable device, etc.)
* Impossibility of lying down without movement for 45 minutes (hyperalgesic patient, claustrophobia, etc.)
* PPGL having previously been the subject of local (excluding surgery) or systemic treatment
* PPGL \<1 cm longest axis
* Patient under guardianship or curatorship
Proactive Care Coordination for Cancer Survivors Who Smoke

This is a population-based randomized controlled trial of 600 patients with a diagnosis of cancer in the past 2 years and registry indicating smoking at the time of diagnosis, that will inform critical questions regarding the relative efficacy of care coordination options, the reliability of Electronic Health Record (EHR) tobacco use data, and how patients will react to proactive tobacco related communications. Investigators will compare the reach and efficacy of two proactive approaches to enrolling cancer survivors in tobacco treatment (Arm 1: mailed care coordination vs. Arm 2: telephone care coordination) using a two-arm randomized design at two urban cancer centers, and will explore cancer survivor attitudes and preferences about proactive tobacco treatment.


Eligibility Criteria:
Inclusion Criteria:

* ICD 9 cancer diagnosis seen at each site in the past two years
* Documentation of current smoking in the cancer registry.

Exclusion Criteria:

* Dementia
* Stage IV or Stage IIIB cancer
Transversus Abdominis Plane Block In Children

Aim of this study; Intra-operative anesthesia and analgesia effects of Transversus Abdominis Plane Block supported by ketamine sedation only.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* To undergo elective lower abdominal surgery
* between 2-6 years old

Exclusion Criteria:

* Patients with psychiatric disease
* Patients whose weight is more than 40 kg
* Patients with cardiac-pulmonary-neurological disease
* Patients with bleeding disorder
* Patients with infection or scar on the injection area
* Patients with known allergies to local anesthetics
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is an adult, female ≥ 18 years old at the time of informed consent
2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
3. Patient is postmenopausal.
4. Patient has T1c-T3, any N, M0, operable breast cancer
5. Patients must have measurable disease
6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
8. Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing

Exclusion Criteria:

1. Patient has locally recurrent or metastatic disease
2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before randomization.
3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus
4. History of acute pancreatitis within 1 year of study entry
5. Uncontrolled hypertension
Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients

Tracheostomy is an important tool in the management of respiratory failure in the critically ill patient under mechanical ventilation. Although mechanical ventilation can be a lifesaving intervention, it is also known to carry several side-effects and risks. Among the most frequent complications of mechanical ventilation, obstruction of the airway secondary to a mucus plug is both life threatening and a prevalent phenomenon related to mucociliary system dysfunction, artificial airway itself and the loss of strength that prevents adequate airway clearance. The main indication of tracheostomy is the need for prolonged mechanical ventilation that usually occurs in more severe patients, this circumstance having also been related to the development of intensive care unit (ICU) acquired weakness. Currently, the approach to secretion clearance in critical patients is focused on rehabilitation therapy and humidification. Hypertonic saline (HS) is largely used in cystic fibrosis to increase airways clearance while little evidence is available in other settings although promising results have been reported. In this sense, the use of HS could be beneficial in the prevention of airway obstruction in tracheostomized critical patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years.
* Respiratory support through tracheostomy performed during ICU stay.
* Informed consent signed by the relatives or legal representative of the patient.

Exclusion Criteria:

* Pregnancy.
* Any terminal disease.
* Known hypersensitivity to any component of Hyaneb (Hypertonic saline of NaCl (7%) in combination with hyaluronic acid).
* Participation in another research study.
* Any other condition that, according to the investigator, may prevent a participant to complete all the procedures required.