cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies

Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days.

Part B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment.

Subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit . The estimated duration of Part B is approximately 64 days.


Eligibility Criteria:
Inclusion Criteria:

* The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed.
* The subject is male or female, ≥18 years of age.
* Subject has a life expectancy ≥12 weeks.
* Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Subject has an irresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma.
* Subject is eligible for ICI treatment.
* Subject is male, or a female who agrees to comply with the protocol contraception method.

Exclusion Criteria:

* Subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure.
* Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.
* Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
* Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
* Subject has any safety laboratory test results (clinical chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
* Subject is pregnant or planning to become pregnant or is lactating.
* Subject has a history of alcohol or drug abuse within the last year.
Collaborative Seamless Care in Oncology : Measure and Reinforce Safety and Adherence to Oral Cancer Treatment

The purpose of this study is to implement a support interdisciplinary program(oncologists, pharmacists, physicians, nurses, leagues against cancer) of medication adherence to oral oncology treatments. The aim is to ensure continuity of care between professionals,effectiveness of treatment and patient safety.

80 patients will be included in swiss-romande hospitals and private oncologists and followed by thirty study pharmacies. Each refusal and drop-out will be documented. Follow-up duration is 48 weeks, with a motivational interviewing at least every three months. Patient adherence will be assessed electronically by MEMS (Medication Event Monitoring System).

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Treated for a cancer with oral medication (letrozol, exemestan,imatinib, sunitinib, nilotinib, everolimus, deferasirox)
* French speaking

Exclusion Criteria:

- None
Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room

The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.

Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough pain relief in oncologic patients.

The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions.

Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.

Safety issues like control of vital signs will be warranted

Eligibility Criteria:
Inclusion Criteria:

* Trauma on the limbs with a pain score of 4 or more
* ASA I - II

Exclusion Criteria:

* children \< 18 years
* cognitive impairment: brain injury, intoxication, analgesia
* weight under 50 kg and more then 100 kg
* other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
* chronic analgesic use or misuse
* allergy
* fear of needles
* pregnancy
* speech difficulties
Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

The study design includes two cohorts that will be treated separately. Phase 1 will include two diabetes cohorts (Type 1 diabetes mellitus and Type 2 diabetes mellitus) who will be randomized independently into two groups, Group 1-CGM and Group 2-SMBG.

The Group-1 CGM cohort who have Type 1 diabetes mellitus will be eligible for Phase 2. Phase 2 will include a separate independent randomization of either MDI therapy (Group 1a- CGM/MDI) or CSII therapy (Group 1b-CGM/CSII).

Additional assessments will be made to evaluate the incremental benefits of changing the insulin delivery method from MDI to CSII in patients already using CGM.

Cost effectiveness and quality of life will be measured between the two groups in each phase.

Eligibility Criteria:
Inclusion Criteria:

* Age 25 years or older
* Diagnosis of Type 1 diabetes mellitus or insulin-requiring Type 2 diabetes mellitus
* Followed regularly by a physician or diabetes educator
* Using multiple daily injections
* stable control of diabetes
* willing to wear a device such as pump or continuous glucose monitor

Exclusion Criteria:

* recent or planned use of non-insulin injectable hypoglycemic agents
* Pregnancy or planning to become pregnant during the study
* Medical conditions that make it inappropriate or unsafe to target an A1C of \<7%
* Renal disease with Glomerular Filtration Rate \<45
* Extensive skin changes/disease that precludes wearing the sensor on normal skin
* Known allergy to medical-grade adhesives
* Recent hospitalization or emergency room visit in the 6 months prior to screening resulting in primary diagnosis of uncontrolled diabetes
Improving Measurement Of Parents' Understanding Of Research Permission

Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaustive information may inhibit rather than promote understanding. Moreover, technical wording in tools used to measure parent understanding of research permission may also lead to inhibition of understanding. This study will test the hypothesis that, among parents of potential subjects for greater-than-minimal-risk research, two modified and simplified subset of questions from the Deaconess Informed Consent Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice, will increase subject understanding of the nature and risks of the research. The study will enroll the parents of 40 potential neonatal research subjects with an interim analysis of data at 20 subjects. Subjects will review a sham research permission form and will be randomized 1:1 to complete one of the two modified comprehension tests in addition to the DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in order to qualitatively describe their opinions of each test. A subset of parents who have received the written form will also undergo a cognitive interview about the form. A similar subset will also be given an open-ended survey about a proposed permission form cover sheet. The primary outcome will be the correlation of scores between the DICCT and modified comprehension tests, following the sham informed consent process.


Eligibility Criteria:
Inclusion Criteria:

* Parents of potential subjects eligible for a NICHD Neonatal Research Network (NRN) interventional trial ("Hydrocortisone/Extubation") or greater-than-minimal risk observational trial ("PROP")
* Permission being sought for a qualifying study
* English speaking

Exclusion Criteria:

* Permission has not been previously sought for another qualifying study
* Illiteracy (unable to read simple forms)
Use of Immersive Virtual Reality to Train the Multisensory Processing Capacities of Children Aged 8 to 16 Years-old With an Autism Spectrum Disorder: Single-center Randomized Pilot Study in Parallel Groups - SEVIRE. (Sensory Virtual Reality)

Autism Spectrum Disorder (ASD) is defined as a neurodevelopmental disorder that affects the functioning and development of social communication (DSM5 - 2013). ASD causes particularities in sensory treatments (auditory, visual), qualified as uni-modal. Added to this, there is difficulties to deal with prevailing stimuli of the environment (pluri-modal) ; parents report the discomfort of their child in this situation with "noisy" behavioral manifestations. Therapeutic social skills programs most often address the subject's lack of adjustment to their environment through understanding social rules and codes and cognitive treatment of situations.

Thus, in order to relieve the sensory modulation disorders which can be the cause of social adjustment difficulties, it's propose to exercise the sensory habituation of children with ASD thanks to virtual reality scenarios restored in 3D immersion booth (the CAVE). The child will be exposed to multimodal stimulation during immersion sessions reproducing the conditions of an ecological environment. A therapist will accompany the child in the CAVE throughout the session.

The investigators hypothesize that regular and repeated exposure to a simulated environment in the CAVE can improve multisensory treatment capacities and have a beneficial effect on the autonomy of children and adolescents with ASD in everyday situations.


Eligibility Criteria:
Inclusion Criteria:

* Child / adolescent aged 8 to 16 years, diagnosed with ASD (DSM-5, ADOS, ADI-R criteria).
* Without intellectual delay (QNV\> 70, WISC-IV or V, WAIS-III or IV).
* Benefiting from a treatment program at the University Center for Child Psychiatry (CHRU Bretonneau-Tours).
* Schooled in the ordinary school context (primary school, middle school, high school, ULIS).
* Having expressed their agreement to participate in the study.

  * Whose parents or legal representatives have signed written consent.
  * Whose parents or legal representatives are affiliated or beneficiaries of a social security scheme.

Exclusion Criteria:

* Neuromotor disorders.
* Uncorrected visual disorders.
* Hearing impairment.
* Known epilepsy.
* Anxiety syndromes identified.
* Hyper ADD / H type activity.
* Treatment with methylphenidate. - Rare genetic syndrome.
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial (Optilaryngo)

Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.

So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.


Eligibility Criteria:
Inclusion Criteria:

* suspension laryngoscopy

Exclusion Criteria:

* THRIVE contraindication:
* epistaxis
* undrained pneumothorax
* Recent gastroesophageal surgery (1months)
* Skull Fractures
Calprotectin, a Biomarker of COVID-19 Severity (CALPRO)

The purpose of this study is to provide new insights into the pathophysiology of emergency hematopoiesis detected in severe COVID-19 patients. The investigators aim to explore the ability of calprotectin to induce an immunosuppressive myeloid program at the hematopoietic stem and progenitor cell (HSPC) level, and to identify the receptor(s) involved in this effect. Since patients with a hematological malignancy demonstrate a very high propensity to develop a severe COVID-19, the investigators will explore how HSPCs collected from patients with a myeloid malignancy respond to calprotectin.

Emergency myelopoiesis in response to SARS-CoV-2 infection produce immunosuppressive myeloid cells with accumulation of immature granulocytes and loss of non-classical monocytes. Excessive release of calprotectin, the dimer of S100A8/A9 alarmins, by immature granulocytes and activated monocytes reflects this situation. A role of calprotectin has been previously described in the initiation and progression of chronic hematological malignancies such as myelodysplastic syndromes.

To provide a rationale for the targeting of alarmin-driven signaling pathways and limit the pathogenic inflammatory response to SARS-CoV-2 infection, the role of calprotectin in the production of immunosuppressive cells from the bone marrow hematopoietic stem and progenitors cells needs to be investigated in patients with severe COVID-19 in comparison with patients with chronic myeloid malignancies (such as chronic myelomonocytic leukemia and myelodysplastic syndromes) and with age-mached healthy controls.

A comprehensive and integrated multiomics approach will be used to decipher the features of immunosuppressive cells and identify therapeutic targets in deregulated pathways.

Eligibility Criteria:
Inclusion Criteria:

Criteria for all groups:

* Adults ≥ 18 years
* Dated and signed inform consent \*

  * \* : written informed consent of relative (trusted person, close family) in case of emergency procedure, by default emergency inclusion notified in medical file and pursuance consent sought.
* Affiliation with a social security scheme

Criteria for control group:

* Age-matched healthy donors

Criteria for chronic myeloid malignancies:

* A diagnosis of low or high-risk myelodysplastic syndromes according to the WHO 2016 classification
* A diagnosis of dysplastic or proliferative chronic myelomonocytic leukemia according to WHO 2016

Criteria for COVID-19 patients:

* Patients with a recent diagnosis (\<7 days since first symptoms) of moderate or severe COVID-19

Exclusion Criteria:

* Pregnant women
* Minor patient or major under protection
* Patients with COVID-19 infection and active cancer or a history of cancer within the last 6 months
* Patients with COVID-19 and severe comorbidities including cardiovascular or respiratory diseases, unbalanced diabetes, obesity (IMC \>29)
* Patient on AME (state medical aid)
Determination of the Effects of Motor Imagery on Learning Infant Massage

Motor imagery is the mental rehearsal of simple or complex motor movements in which no clear body movement occurs. It can also be defined as the mental simulation of movement without revealing any real motor movement. Studies have shown that similar brain regions are activated during the performance of the movement and the imagery of the movement. According to the results obtained from advanced imaging techniques, it has been reported that activations occur in similar areas during motor imagery and physical performance, including brain areas such as premotor areas, parietal lobe, basal ganglia, anterior cingulate cortex, and cerebellum. When the literature is examined, it has been seen that motor imagery applications are used in many different areas. In 2021, the effect of motor imagery training on students' motor imagery levels and practice in the education of medical school students by Collet et al. was investigated. As a result of the training, it was reported that motor skills improved and it strengthened the learning of medical skills.

Infantile colic was first defined in 1954 by Wessel et al. The incidence of infantile colic varies between 10-30%. There was no study showing the general colic frequency in Turkey, however, in a study conducted in the Eastern Anatolia Region in 2005, the incidence of infantile colic was reported as 51.1%. Although the causes of colic are not fully explained, food allergy or lactose intolerance, hypersensitivity, abnormal peristalsis or excessive gas, tension and stress in the family, swallowing air during bottle feeding or excessive crying, gastro-esophageal reflux, low birth weight, psychosocial It is thought that factors such as problems cause colic.

Thus, in physiotherapy education, there are many practical lectures. In the recent years, motor imagery has been used to teach exercises to the patients who need physiotherapy like stroke patients. Thus, it is considered that motor imagery can be used in the education and in the literature, there are papers which investigate the effects of motor imagery among the students of nursing and medicine. In conclusion, the aim is to see whether this method can be used as a new teaching method among physiotherapy students, thus this may bring the students more familiar for the use in their future clinical practices.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18
* To be taking the Pediatric Rehabilitation course for the first time in the Fall semester of the academic year 2022-2023 at the Eastern Mediterranean University, Department of Physiotherapy and Rehabilitation.

Exclusion Criteria:

* Having serious vision and hearing problems,
* Having serious attention problems,
* Having a musculoskeletal, cardiovascular, pulmonary, metabolic, or other disease severe enough to preclude participation in the study.
* Prior participation in any kind of motor imagery training
Prediction of Fluid Responsiveness in Children With Single Ventricle

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).

The purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and Fontan tract).

When there are clinical signs of hypovolemia, such as hypotension, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.

To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration.

Finally, patients will be divided into fluid responder group and non-responder group. If cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. Using ROC curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery
* Patients with bidirectional cavopulmonary shunt or fontan tract

Exclusion Criteria:

* renal, hepatic and pulmonary disease
* preoperative infection: increased CPR, WBC over 10,000, and with fever
* genetic and hematologic disease
* ventricular dysfunction
* increased intracranial pressure
Open-Label Study of ARD-0403 in Testosterone Deficient Men

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility Criteria:
Inclusion Criteria:

* Testosterone deficiency

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy, or prostatic cancer
* Haematocrit \>50%
Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice

This is an observational, multicenter study in participants treated with nivolumab for the approved indications of melanoma and Lung cancer in Australia, the EU, Switzerland, the United Kingdom (UK), and the United States (US). The targeted countries in the EU for study participation include Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, and Spain. Study objectives are to assess the safety experience, survival, adverse event management, and outcomes of adverse events associated with nivolumab in routine oncology care facilities.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Histologically or cytologically confirmed diagnosis of melanoma (including uveal melanoma) or lung cancer
* Treatment with commercial nivolumab for the first time, alone or in combination with ipilimumab, for the approved indications of nivolumab within 14 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy is determined before an informed consent to study participation, and treatment is initiated within 28 days after informed consent

Exclusion Criteria:

* Prior participation in a clinical trial within the past 4 weeks
* Previously treated with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies
* Previously treated with anti-CTLA-4 for lung cancer
* Current or pending participation in a clinical trial
* Current or pending systemic treatment for cancer other than melanoma and lung cancer
* Inability to comply with the study protocol
The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief

The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.


Eligibility Criteria:
Inclusion Criteria:

* History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
* BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
* Not taking contraception or other types of medication that could influence reproductive status
* Regular menstruation
* Medically free from chronic diseases
* Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts)
* History of analgesic pill intake during menstruation
* No pelvic pathology

Exclusion Criteria:

* Amenorrhea
* On a form of contraception
* Secondary dysmenorrhea and/or other gynecological problems that may cause pain
* No discomfort, pain, or other symptoms during menstruation
* History of surgery over lower abdomen area
* Allergy to ibuprofen
* Cardiac disability
* Pacemaker
* Arterial disease
* Uncontrolled hemorrhage
* Blood clots
* Pregnancy or trying to become pregnant
* Cancerous lesions
* Exposed metal implants
* History of seizures
* Sensory or mental impairment
* Unstable fractures