cyrilzakka/clinical-trials huggingface dataset:
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer

This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 and older
* Confirmed diagnosis of hormone receptor-positive breast cancer.
* Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
* ECOG 0-2
* Adequate organ function

Exclusion Criteria:

* Subjects disable to swallow pills.
* History of immunodeficiency disease
Effects of Physical Activity on Quality of Life Among Female Undergraduate Students

The main objective of the study is to determine the effects of physical activity on quality of life among female undergraduate students


Eligibility Criteria:
Inclusion Criteria:

-moderate level of academic stress measured on academic stress scale

Exclusion Criteria:

* students with diagnosed psychological disorders
* systematic diseases
Defining Normal Citrulline Levels as a Diagnostic Tool for Screening of Gastrointestinal Disease in Premature Infants

Since the first description of citrulline as a potential marker for intestinal function in 1998, its use has been investigated in a variety of disease processes including Short Bowel Syndrome, Celiac disease, chemotherapy and radiation induced intestinal injury, infections producing intestinal cytopathic effects like Adenovirus, and predicting rejection in intestinal transplantation. The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.

The introduction of enteral nutrition in the premature infant is a process of trial and error, knowing that the immaturity of the gastrointestinal system may lead to frequent episodes of feeding intolerance. This is augmented by the fear of the development of necrotizing enterocolitis (NEC) once feeds are commenced. NEC is a condition characterized by disruption of the intestinal epithelial barrier, a pathogenic process shared with some of the conditions mentioned above for which citrulline has proven clinically useful.

A normal pattern of citrulline production has not been established in the premature population. Previous studies have shown decreased levels of glutamine and arginine in premature infants up to 10 days prior to the development of necrotizing enterocolitis. Glutamine and arginine are two amino acids closely involved in the synthesis and catabolism of citrulline.

The investigators therefore hypothesize that defining a normal pattern of citrulline production in the premature population may prove to be a clinically useful diagnostic tool to screen for gastrointestinal disease.

The use of citrulline levels as a diagnostic tool to predict gastrointestinal disease in the premature population has not been properly addressed.

Eligibility Criteria:
Inclusion Criteria:

1. Premature infants with gestational age between \<32 weeks regardless of birth weight

Exclusion Criteria:

1. Inborn errors of metabolism
2. Need for exchange transfusion
3. Multiple congenital anomalies
4. Renal failure (defined as urine output \<1ml/k/h \>24h, creatinine \>1.8, or diagnosis of "non-oliguric renal failure" as determined by Pediatric nephrology)
Subcutaneous Nitroglycerin to Prevent Radial Artery Occlusion in Children

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin to prevent radial arterial occlusion(RAO) after removal of the radial arterial catheter in pediatric patients. The hypothesis of this study is that subcutaneous nitroglycerin will decrease the incidence of radial arterial occlusion after radial arterial catheter removal in pediatric patients by increasing the radial artery size. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation and catheter removal in pediatric patients. Prior to the procedure, each patient will be randomized into either the control arm, saline, or the study arm, nitroglycerin.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing General anesthesia
* Patients in the Intensive care unit
* Arterial cannulation for hemodynamic monitoring, or multiple blood sample

Exclusion Criteria:

* Unstable vital signs, significant arrhythmia or hypotension, Shock
* High risk of peripheral ischemia
* Skin disease, infection, hematoma, recent cannulation at the radial artery
* History of anaphylaxis to nitroglycerin
Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service

In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The main objective is to compare the prognostic performance of SEPSIS 3 against the previous strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital death.

This study compare the prognostic performance of two strategies. It's a monocentric, retrospective study in patients admitted to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Aged of 18 years or more
* Initiation of one or more antibiotics in the Accident and Emergency Department in the Metz-Thionville hospital (CHR) site Mercy, for curative purpose, regardless of the infectious aetiology
* Hospitalized in the CHR Metz-Thionville thereafter

Exclusion Criteria:

* Minors patients
* Absence of antibiotic treatment initiated in the Emergency department
* Prescription of antibiotic treatment in the emergency department for preventive purpose
* Transferred by hospitalisation service of CHR Metz-Thionville in the emergency department
* Absence of hospitalisation following their passage through the emergency department
* Transferred to hospitalisation in an other establishment
* Presence, at the admission, of an antibiotic treatment
* Patients deceased in the emergency department
The Breathe Well Program for Adults With Asthma

The Breathe Well Study is a pragmatic, controlled trial to assess the effectiveness, cost-effectiveness, and implementation of the Breathe Well intervention, which combines evidence-based EHR and interactive behavior-change technologies (IBCT) and team-based care to improve asthma outcomes.

Breathe Well uses the Kaiser Permanente Electronic Health Record (EHR) to identify asthma exacerbation risk factors. For patients with a history of frequent exacerbations or B-agonist overuse, the EHR notifies a nurse who uses an EHR-generated tailored clinical report and patient directed decision support tool to engage and empower patients to develop an action plan in collaboration with providers. EHR-templated notes and order sets facilitate care plan execution. Poor controller medication adherence or unaddressed smoking results in the patient being automatically enrolled in an IBCT medication refill or smoking cessation program. Breathe Well uses multiple EHR functions and a patient and provider team to address barriers to evidence-based asthma care for providers.The study will be conducted in 26 primary care clinics of Kaiser Permanente Colorado (KPCO) using a pragmatic clinical trial design. Up to 15,000 high-risk asthma patients will be assigned to Breathe Well or guideline-based usual care based on their clinic.

Eligibility Criteria:
Inclusion Criteria: Adults with ≥1 EHR of these indicators of an asthma care gap in the EHR will be eligible.

1. B-agonist overfilling
2. inhaled corticosteroid (ICS) underfilling
3. current smoker
4. asthma exacerbation in the last year

Exclusion Criteria:

1. limited life expectancy
2. diagnosis of chronic obstructive pulmonary disease
3. lack of a pharmacy benefit because medication use cannot be captured.
Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Recurrent Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

The purpose of the Family Help Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 106 children (9-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Recurrent Headache/Abdominal Pain will be randomized.

The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.

Eligibility Criteria:
Inclusion Criteria:

* child 9 to 16 years of age
* child had recurrent headache and abdominal pain at least 3 times a month
* child's physical examination normal
* access to a telephone in the home
* speak and write english
* mild to moderate anxiety symptomology

Exclusion Criteria:

* child's pain due to trauma, systemic disease or disorder
* child received any psychological treatment for this or similar disorder in the past 6 months
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
3. Patients who have smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.70.

Exclusion Criteria:

1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
2. Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
7. Patients with uncontrolled Type I and Type II diabetes.
8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (\>450 ms for males or \>470 ms for females).
11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.
Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease

This is a prospective randomized controlled trial investigating the impact of educational bidirectional text message reminders on gluten free diet adherence among adolescents and young adults with celiac disease age 12-24. Participants will complete a series of online questionnaires assessing quality of life, patient activation, celiac symptoms, and self reported dietary adherence at the beginning and end of the study. Participants will also have their blood drawn to measure Tissue Transglutaminase IgA (TTG IgA) antibody and Deamidated Gliadin Peptide IgA (DGP IgA) at the beginning and end of the study. Lab draws can be done locally, and are at no cost to the participant. Patients are randomized to the intervention or control group based on enrollment TTG IgA. Intervention group receives 45 unique text messages over the 3 month study. A gift card is provided for participation in the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 12-24
* Celiac disease diagnosed by a gastroenterologist at least 1 year prior to enrollment
* Participant with ability to read email and text messages in English
* Access to a mobile phone
* Unlimited text messaging plan or agreement to receive 45 text messages for the study

Exclusion Criteria:

* Participant inability to answer survey questions and text prompts in English
Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support

The purpose of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online, in a comparison of outpatients seeking treatment for substance use disorder who receive standard care with group peer support, versus with access to Breaking Free Online, versus with access to Breaking Free Online and individual peer support.

A total of 225 outpatients receiving standard care for substance use disorder from the Centre for Addiction and Mental Health will be randomized to receive clinical monitoring (CM) with group peer support, Breaking Free Online only, or Breaking Free Online with individual peer support, in an eight-week trial with a six-month follow-up period. The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement, and cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and above
2. Fluency in English
3. Understanding and willingness to comply with study requirements \& provide informed consent
4. Current substance use disorder
5. Have used alcohol or substances within the past 30 days
6. Registration with CAMH Addictions Program outpatient services

Exclusion Criteria:

1. Current psychosis or mania
2. Current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention
3. Significant neurological disorder or physical illness likely to interfere with participants
4. Any known practical factors that would preclude participation (e.g., extended absences)
5. Inability to read at a sixth grade level
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for Part A,and from 2 to 35 months old (i.e. ≥ 2 months old and \< 36 months old) for Part B at the time of first vaccination.
2. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
3. Subject is able and can comply with the requirements of the protocol.
4. Subject with body temperature ≤38°C.

Exclusion Criteria:

1. Subject with previous known exposure to Enterovirus 71 (EV71).
2. Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
3. Subject with gestation \< 37 weeks.
4. Subject with birth weight \<2.5 kg.
5. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
6. Family history of seizures or progressive neurological disease.
7. Family history of congenital or hereditary immunodeficiency.
8. Severe malnutrition or dysgenopathy.
9. Major congenital defects or serious chronic illness, including perinatal brain damage.
10. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
11. Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
12. Any acute infections 7 days prior to administrating the first vaccination.
13. Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
14. Administration of any vaccines within 14 days prior to randomization.
15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
16. Chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
17. Subjects who had ever received investigational EV-71 vaccine prior to randomization.
18. Under anti-tuberculosis prevention or therapy.
19. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.

The total duration of the study period per patient is 10 ± 1 day

Eligibility Criteria:
Inclusion Criteria:

* Quick-test positive for Streptococcus pyogenes;
* Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation;
* Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3;
* Presence of at least two of the follow symptoms:

  * Hyperemia and edema evaluated with at least 2 out of 4 crosses
  * Fever in the previous 48 hours
  * Cervical adenomegaly
  * Tonsilla with erythema or erythema and white exsudate.

Exclusion Criteria:

* History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions;
* History and laboratorial confirmation of hematologic, hepatic or renal disorders;
* Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months;
* Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours;
* History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of CES1 Genotype on Metabolism of Methylphenidate

The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of methylphenidate, a CES1 dependent drug.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* Caucasian

Exclusion Criteria:

* Chronic disease (except hay fever and eczema)
* Pregnancy
* Smoking
* High level of alcohol consumption (\> 21 units per week for men and 14 for women)
* Known allergy towards methylphenidate
* Permanent use of medication (contraception ok)
Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors

Up to 78% of women diagnosed with breast cancer experience impairments in their cognitive function (e.g., frequent forgetfulness, slow processing speeds, and difficulties in concentration, multitasking and/or word retrieval) in the course of cancer treatment. These cognitive impairments (CI) have negative effects on patients' social relationships, overall life satisfaction, and treatment adherence. Dietary intake may be an important factor in mitigating risk of CI that breast cancer patients experience. Several studies have suggested that dietary intake of specific nutrients and foods (e.g., carotenoids, B-vitamin, and omega-3 fatty acids rich foods) can be helpful to decrease the severity of cancer-related cognitive impairment (CRCI). High-quality dietary patterns can be also helpful to protect white matter volume and its integrity; damage to and changes in white matter contributes to CRCI. However, despite the high incidence of CRCI in breast cancer patients, very little is known about etiology of CRCI. Thus, the purpose of this observational study with cross-sectional design is to examine the relationships of diet with brain structural and functional outcomes of breast cancer patients. The study will aim to enroll 30 female postmenopausal breast cancer survivors (age 45-75) who have recently completed chemotherapy treatment within 3-12 months from study enrollment. Participants will complete study questionnaires online, and will have an in-person study visit to complete a functional magnetic resonance imagine (MRI) scan, cognitive testing, and blood sample collection via fingerstick and venous blood draw. It is expected that this study will advance the field's understanding and ability to early assess, manage, and prevent CRCI.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer diagnosis
* Between 3-12 months post-treatment with anthracycline or taxane-based chemotherapy
* Postmenopausal (at least 12 months without menses; OR on ovarian suppression medication; OR status post oophorectomy)
* English speaking

Exclusion Criteria:

* Women who have permanent ferromagnetic metal in the body, a pacemaker, or have severe claustrophobia
* Women who are pregnant or breastfeeding
* Diagnosis of dementia, psychosis, alcohol or substance use disorders
* Concurrent other malignancy or metastatic malignancy of any kind
* Unable to give informed consent.