cyrilzakka/clinical-trials huggingface dataset:
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France

This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.

Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.

Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height \& weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.

Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving Saizen® via Easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving Saizen® via Easypod™
* To identify adherence subject profiling
* To asses the Impact of adherence on insulin-like growth factor-1 (IGF1) ranges/levels

Eligibility Criteria:
Inclusion Criteria:

* Administered Saizen® via the Easypod™ electromechanical device according to pediatric registered indications (Growth Hormone Deficiency, Small for Gestational Age, Turner-Syndrome or prepubertal children with Chronic Renal Failure).
* Naïve subjects or already treated with Saizen and Easypod for maximum 1 year
* Male and Female between 2 - 18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's (or subject if over 18 without fusion of growth plates) written agreement, given before entering data into the study, with the understanding that the subject or parent/guardian may withdraw agreement at any time without prejudice to future medical care.

Exclusion Criteria:

* Subjects taking Saizen® in whom growth plates have fused (i.e. taking growth hormone for it's metabolic effects)
* Contra-indications to Saizen® as defined in the French Summary of Product Characteristics (SmPC)
* Use of an investigational drug or participation in an interventional clinical study
Robot-assisted Procedure Versus Open Simultaneous Resection of Colorectal Cancer With Liver Metastases

The purpose of this study is to evaluate the safety and effectiveness of robot-assisted simultaneous resection in selected patients with sigmoid colon cancer or rectal cancer liver metastases, and compared with the traditional open procedure.

The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years;
2. Primary tumor has undergone histologically confirmed colon adenocarcinoma; Colon cancer was defined by the presence of the inferior pole of the tumor above the peritoneal reflection (at least 15 cm from the anal margin).
3. Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system);Liver metastasis was diagnosis by multidisciplinary (MDT) team base on liver Magnetic Resonance Imaging (MRI) and Positron Emission Computed Tomography (PET-CT).
4. Performance status (ECOG) 0\~1
5. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
6. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
7. Written informed consent for participation in the trial.
8. The liver resectability was evaluated by liver surgery of MDT team, indication including: tumor number ≤ 3; the Maximum diameter of one tumor ≤ 10 cm.

Exclusion Criteria:

1. Body mass index (BMI) more than 30 kg/m2.
2. Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
3. History of accepting abdominal surgery.
4. Liver tumor located at I or invasive the middle hepatic vein.
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer

This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.


Eligibility Criteria:
Inclusion Criteria:

- Untreated pathologically or cytologically-confirmed diagnosis of stage IB3 (\> 4cm), II, III, or IVA (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix not amenable to curative surgery alone.

Exclusion Criteria:

* Presence of another concurrent active invasive malignancy
* Prior invasive malignancy diagnosed within the last three years except for \[1\] non-melanoma skin cancer or \[2\] prior in situ carcinoma of the cervix
* prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician.
Cognitive Intervention to Improve Memory in Heart Failure Patients

Cognitive Intervention to Improve Memory in Heart Failure patients

A three arm randomized controlled trial of 276 heart failure patients.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Understands English
* Has access to a telephone
* Hears normal conversation
* For patients with hearing aids, able to wear and hear through headsets
* Diagnosis of chronic heart failure, stage C, NYHA I, II or III
* Receiving guideline derived medical therapy
* Heart failure validated by echocardiography or other method in past 2 years
* Able to read a computer screen with or without glasses or lenses

Exclusion Criteria:

* History of drug or alcohol abuse or major psychiatric diagnosis present before the heart failure diagnosis
* Alzheimer or other dementia diagnosis or central nervous system degenerative disorder
* Terminal cancer
* Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19

Supplement Eligibility: First 144 patients randomized in the parent trial.
Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives

Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50% of these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs. A common underlying factor of such events is inadequate communication between patients and medical personnel. General practitioners (GP) often initiate the treatment of hypertension, being generally the first prescribers of these medications. 12.6% of the patients present an ADE with hypertensive drug after 3 months. The InPAct procedure is a tool to facilitate communication in order to improve patient safety in primary care. In the context of the primary care prescription of an antihypertensive drug, the GP informs the patient about hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs, which helps the patient to detect and declare situations involving a heightened risk of antihypertensive-related ADEs. The aim of the InPAct study is to evaluate the efficiency of the InPAct intervention in primary care.

A stepped wedge cluster randomized study, with 8 clusters and 5 periods of 3 months each. Each cluster is composed of about ten general practitioners. The InPAct intervention will not be presented to the first patients recruited by each general practitioner, whereas it will be presented to all their last patients. The period of intervention introduction by each general practitioner will be randomized amongst the 5 periods.

Eligibility Criteria:
Inclusion Criteria:

* Patient monitored for essential hypertension requiring a first prescription, a renewal or a change of antihypertensive drug treatment
* Patient with the ability to understand and express themselves in French
* Patient accepting to communicate his phone number and accepting a telephone survey within the fourth month following its inclusion in the study.

Exclusion Criteria :

* Patient with a psychiatric disorder or a progressive dementia.
* Patient with hypertension in pregnancy or secondary hypertension.
* Patient with an acute hypertensive crisis.
* Patient under guardianship.
* Patient who is likely to move or may have an irregular follow up within 6 months following its inclusion in the study.
Evaluating the Effectiveness of the Calm Moments Cards Program Implemented by School Personnel

We explored the meaning and outcomes of a 4-month program designed to build capacity of school personnel in implementing evidence-based strategies for reducing stress and promoting mental well-being among students in school settings. A one-group (N 93) mixed-methods design using a pretest-posttest survey and qualitative analysis of their written reactions was used to explore the meaning and outcomes of the Calm Moments Cards program.

In order to explore the effectiveness of the Calm Moments Cards program on school personnel's ability to recognize signs of stress and the implementation of embedded strategies to reduce stress and enhance emotional well-being, we conduct a mixed-methods research study using pretest-posttest surveys (assessing knowledge, beliefs, and actions) and qualitative analysis of written reflections about the meaning and use of the Calm Moments Cards. The focus of the intervention is on prevention of stress and anxiety based on situational stressors (e.g. taking a test, completing an assignment) so that students can focus on and succeed in doing their schoolwork. Occupational therapy practitioners oriented school personnel to the signs of stress and the use of the 17 Calm Moments Cards using a 1 hour inservice. This was followed by informal coaching to foster implementation.

Eligibility Criteria:
Inclusion Criteria:

* School personnel representing teachers, related service providers and para-educators working with elementary students in schools

Exclusion Criteria:

* School personnel who were informed of but declined to participate in the study
PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases

ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED).

In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC.

Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.

Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven SCLC
* measurable disease defined by RECIST criteria

Exclusion Criteria:
Photobiomodulation in Palate Wounds: Somatosensorial Evaluation

The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Palate with normal and healthy mucosa
* Patient with indication of gingival graft surgery

Exclusion Criteria:

* Patients using prosthesis with palate coverage
* Former removal of gingival graft in the palate
* Smokers
* Pregnancy and breastfeeding mothers
* Use of anticonvulsants and immunosuppressors
Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.

This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and over) with back pain of any duration
* Seeking primary care for back pain at a participating site
* Primary care visit may be a first or repeat visit

Exclusion Criteria:

* Patients who do not consent to participation
* Patients who report being unable to understand, read, and write English
Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects

The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy Subject Cohorts:

* Healthy male or female subjects
* Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)

Type 2 Diabetic Subject Cohorts:

* Male or female Type 2 diabetic subjects diagnosed for at least 3 months
* BMI between 25 and 40 kg/m2 (inclusive)
* Have a glycosylated hemoglobin (HbA1c) of \>6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR \>6.5% to ≤10.0% (inclusive) if treated with metformin

Exclusion Criteria:

Healthy Subject Cohorts:

* Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic, and dermatological or connective tissue disease
* Subjects with a systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg

Type 2 Diabetic Subject Cohorts:

* Subjects with a known medical history or presence of type 1 diabetes mellitus
* Subjects with known medical history of acute metabolic diabetic complications
* Subjects with uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>95 mmHg with documented ongoing treatment)
Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis

An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.

Eligibility Criteria:
Inclusion Criteria:

* Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
* Patient has anterior interventricular stenosis
* Patient signed the informed consent form
* Patient is covered by health insurance

Exclusion Criteria:

* Patients with beating heart surgery indication (no extracorporeal circulation required)
* Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
* Iterative surgery
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)

In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk.

The aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.


Eligibility Criteria:
Inclusion Criteria:

* diplegia and CP;

Exclusion Criteria:

* severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV
* pharmaco-resistant epilepsy
* behavioural disorders
Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Diagnosed ulcerative colitis
* Signs of clinical activity with SCCAI of 3 or more
* Extension more than 10 cm and no more than 40 cm from anus

Exclusion Criteria:

* Rectal temperature more than 38 degrees Celcius
* Diagnosed celiac disease or lactose intolerance
* Unable to speak or understand Danish
* Prior biologics or systemic steroids 4 weeks up to inclusion
Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT

In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one or multiple pathologically proven malignancies in the head and neck region (targeted lesions), independent of origin and stage.
* Patient is planned for the surgical resection of the targeted lesion.
* Age ≥ 18 years.
* Karnofsky performance scale ≥30
* Patient has given informed consent according to the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines in accordance with the declaration of Helsinki.

Exclusion Criteria:

* Patient is planned for a treatment regimen which does not include standard surgical resection of the targeted lesion.
* Pregnant or actively lactating women.
* Blood glucose level ≥ 200mg/dl or more on the day of surgery.