cyrilzakka/clinical-trials huggingface dataset:
A Phase II, Trial of Ixabepilone Plus Cetuximab as First Line Therapy for Metastatic Pancreatic Cancer

The purpose of this clinical research study is to learn if ixabepilone plus cetuximab improves survival when given as 1st line chemotherapy in subjects with metastatic pancreatic cancer compared to historical data. The safety of this combination treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of pancreatic adenocarcinoma (locally advanced disease that is not surgically resectable, or distant metastatic disease)
* Participants must have measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines
* Participants must not have received prior chemotherapy, immunotherapy or chemoradiotherapy for advanced pancreas cancer
* Karnofsky performance status (KPS) of 70-100
* Adequate hematologic, hepatic and renal function
Comparison of Upper and Lower Extremity Isometrics on Cognition in Healthy Adolescents

This study aims to compare the effects of upper and lower-extremity isometrics on cognition in healthy adolescents.

The literature suggests a positive impact of isometrics on cognition. Identifying how cognitive results would differ in upper vs. lower extremity isometric groups is the main objective of the study. for cognitive assessment, different aspects of cognition will be measured by all computer-based tools (except for Trail making A and B).

Eligibility Criteria:
Inclusion Criteria:

* School-going adolescents
* Both male and female students with a minimum age of 12 and a maximum of 18yrs
* Students with good school attendance
* Subjects who are willing to commit to the time commitments required by the program

Exclusion Criteria:

* Students with Physical or mental disabilities
* Those who suffered a fracture before
* Students with any morbidity
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)

Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high risk of developping the same disorder and/or a psychopathology. Early intervention focused on emotion and problem solving strategies could improve their prognosis.

The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity. Children emotional dysregulation profile will be compared before and after this CBT intervention.


Eligibility Criteria:
Inclusion Criteria:

* Children and teenagers from 6 to 16 years-old
* At least one biological parent with bipolar disorder
* T-score CBCL-Total ≥ 60
* Written informed consent

Exclusion Criteria:

* Active severe thymic episode
* Autism spectrum disorders
* Intellectual disability
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal outpatients women \> 55 and \< 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture).

Exclusion Criteria:

* History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission.
* Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Dexmedetomidine and Propofol in Mechanically Ventilated Patients by Using Salivary Alpha-amylase as a Stress Marker

The aim of this study is to compare the efficacy of dexmedetomidine and propofol on decreasing stress in mechanically ventilated patients by using salivary alpha-amylase as a stress marker.

Critically ill patients receiving mechanical ventilation (MV) in the Intensive Care Unit (ICU) have been reported to suffer due to their sense of dependency on technical medical equipment and from severe emotional responses such as hopelessness, anxiety, high levels of frustration and stress. The administration of sedatives is intended to reduce and/or prevent these negative experiences and to facilitate nursing care.

Dexmedetomidine is a highly selective α2 receptor agonist with 1600-fold affinity to α1 receptor. The use of dexmedetomidine before anesthesia has a positive effect on hemodynamic stability, which has been associated with reduced postoperative mortality and reduction of unpleasant postoperative complications . Dexmedetomidine has been shown to provide good patient comfort during MV; it also has a satisfactory safety profile and reduces time to extubating.

Salivary alpha amylase (SAA) will be considered as a suitable biomarker of sympathetic nervous system activity in recent years. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old.
* Both sexes.
* Newly mechanically ventilated.

Exclusion Criteria:

* Patients who used inhaled steroids.
* Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
* Those with smoking and drinking habits.
* Patients on adrenoreceptor agonist or antagonist therapy.
* Pregnant female.
* Known hypersensitivity to the study drugs.
* Women using oral contraceptive or were in their menstrual cycle.
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen in the first-line treatment of advanced gastric cancer patients.

Eligibility Criteria:
Major inclusion criteria

* had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic
* measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)1.1
* an Eastern Cooperative Oncology Group performance status of 0 to 2
* adequate renal, hepatic, and hematologic function

Major exclusion criteria

* previous chemotherapy or radiotherapy (unless in the adjuvant setting)
* uncontrolled cardiac disease, or other clinically significant, uncontrolled coexisting illness or previous or concurrent cancer
* accumulated dose of Epirubicin exceeds 300mg/m2
* HER2 positive and willing to use trastuzumab
A Registered Cohort Study on Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a kind of motor neuron degeneration disorder without effective therapy. This registered cohort study will provide further insights into the clinical course of ALS, and investigate disease-relative risk factors and the genetic background of Chinese ALS patients.

Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease (MND), which is characterized with highly clinical heterogeneity and no effective treatment is available now. The purpose of this registered cohort is to observe the natural history of ALS patients in China, and then identify some factors correlated with disease progression. Besides, ALS-related gene mutations will be screened and explore novel disease causing gene as well.

Eligibility Criteria:
Inclusion Criteria:

* Amyotrophic Lateral Sclerosis patients fulfilling the El Escorial criteria (including definite, probable and possible)
* Progressive muscular atrophy
* Primary lateral sclerosis
* Progressive bulbar palsy

Exclusion Criteria:

* History of serious head trauma or neuropsychiatric disease
* Decline to participate
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)

The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject has a severe symptomatic AS undergoing a TAVI procedure
3. Subject with a THV for which rapid pacing is considered necessary during valve implantation
4. Subject agrees to participate in the study and is able to sign the informed consent form

Exclusion Criteria:

1. Failure to provide signed informed consent
2. Extremely horizontal aorta (aortic root angle ≥70°)
3. Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
4. Inability to receive full anticoagulation during the TAVI procedure
5. Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

The primary objective of the study is to determine whether short term course of colchicines reduces number of deaths due to COVID-19 and severe complications due to the virus in elderly patients with comorbidities.

The secondary objective is to determine the safety of colchicines in this patient population.

Approximately 954 subjects who meet all inclusion criteria and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment (2:1 allocation ratio) during 21 days. Follow-up assessments will occur every 48 hours and always at day 10, 21 and 61 following randomization for evaluation of the occurrence of any trial endpoints or other adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes who are at least 60 years old.
2. Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR
3. Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences
4. The patient must possess at least two of the following high-risk criteria

   1. 60 years of age or older AND
   2. Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia
5. The patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Hospitalized patient or under immediate consideration of doing so
2. Patient taking colchicine for other indications
3. Patient with history of allergic reaction or sensitivity to colchicine
4. Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption
5. Patient with pre-existing progressive neuromuscular disease
6. Patient with kidney damage and estimated glomerular filtrate rate \<30 ml/m at 1732
7. Patient undergoing chemotherapy for cancer, including haematological malignancies.
8. Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs
9. Immunosuppressive treatment
10. History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.
11. If the investigator considers it, for any reason, to be an inadequate candidate.
12. Patient and/or legal representative will not have signed the informed consent form.
Primary Preventive Ventricular Tachycardia Ablation in High-Risk Patients Who Receive a Prophylactic Implantable Cardioverter Defibrillator

This prospective, multicenter, open-label, randomized-controlled trial compares two treatment strategies in high-risk ischemic cardiomyopathy (ICM) patients referred for primary ICD implantation. Participants will be randomized to receive either prophylactic VT ablation within three months of ICD implantation or continued medical management. The primary objective is to assess the efficacy of preventive VT ablation versus medical management in reducing VT arrhythmia burden.

This study aims to assess the impact of prophylactic catheter-based ventricular tachycardia (VT) ablation compared to medical management in high-risk patients with ischemic cardiomyopathy (ICM) undergoing primary implantable cardioverter defibrillator (ICD) implantation. The primary outcome measure is the burden of VT arrhythmias (VTA), defined as the total number of VT events, one year post-ICD implantation. The hypothesis suggests that employing VT ablation with high-density electroanatomic mapping (EnsiteTM) will significantly reduce both treated and monitored VT episodes. The study will randomize 62 participants in a 1:1 ratio across 20 experienced sites in Europe.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (no upper age limit)
* Willing and able to provide informed consent
* Candidate for a primary prevention ICD/CRT-D per ESC guidelines17
* Ischemic cardiomyopathy (ICM) with left ventricular ejection fraction (LVEF) ≤ 35%
* Willing and able to receive an ICD
* Willing and able to undergo catheter-based VT ablation

One or more of the following:

* MADIT-ICD Benefit Score \>75
* History of nonsustained ventricular tachycardia (NSVT)
* Multiple premature ventricular complexes (PVCs ≥10%)

Exclusion Criteria:

* Existing ICD or CRT-D
* History of sustained VT or VF
* Chronic renal failure requiring hemodialysis
* Coronary revascularization within the past 3 months
* ST-Elevation MI within the past 3 months
* Participation in concurrent clinical trials without approval from the Coordination Center (observational registries are allowed with approval)
* Currently pregnant or planning to become pregnant in the near future
* Inability or unwillingness to adhere to the study protocol
* Inability or unwillingness to provide informed consent for participation
* Life expectancy \< 1 year
Light Therapy to Increase Energy in Adolescents and Young Adults Newly Diagnosed With Solid Tumors: A Pilot Study

Fatigue is one of the most consistent and distressing symptoms reported by pediatric oncology patients. The investigators' work has demonstrated that in the period from diagnosis through the initial 8 weeks of treatment, adolescents and young adults with solid tumors experience substantial fatigue that is not related to sleep disruption. Fatigue can contribute to many adverse outcomes including poor treatment adherence, reduced social activities, depressive symptoms, behavior problems, and poorer quality of life. Unfortunately, no definitive intervention to reduce fatigue has been developed for pediatric oncology patients. Investigators propose a study to estimate the feasibility and acceptability of bright light therapy as an intervention to decrease fatigue in adolescents and young adults who are newly diagnosed and receiving treatment for solid tumors, including lymphoma.

This feasibility and acceptability study will assess the rate of consent to, adherence to, and side effects from a therapy study in a randomized trial comparing bright white light (BWL) to dim red light (DRL). Four questionnaires will be distributed to patients and/or their parents, depending upon the questionnaire, to study the fatigue, quality of life, mood symptoms, and side effects of the BWL/DRL intervention in adolescents and young adults being treated for solid tumors, including lymphoma.

PRIMARY OBJECTIVES:

* To estimate the feasibility and acceptability of a BWL intervention compared to a DRL standard comparison group in adolescent/young adult solid tumor and lymphoma patients.

SECONDARY OBJECTIVE:

* To estimate the effect size of this intervention on measures of fatigue in order to design a larger clinical trial of efficacy of a randomized control trial of BWL versus DRL intervention for fatigue in pediatric oncology patients.

OTHER PRESPECIFIED OBJECTIVES:

* Estimate the effect of participant location (inpatient, hospital-based housing, or home) on adherence.
* Estimate rates of depressive symptoms.
* Describe quality of life.

Eligibility Criteria:
INCLUSION CRITERIA:

* Age 12 years or older
* Has initiated treatment as part of an active St. Jude Children's Research Hospital (SJCRH) treatment plan
* ≤ 30 days post diagnosis of a solid tumor or lymphoma
* Patient speaks, reads and writes in English or Spanish
* Potential participant/guardian is willing to sign informed consent

EXCLUSION CRITERIA:

* Blind or having a history of eye disease including, but not limited to, macular degeneration, or other diagnosed retinal problems
* Undergone laser corrective eye surgery in the past 30 days
* Significant physiological or psychological impairment that interferes with participation (e.g., migraines, bipolar disorder, psychosis, seasonal affective disorder)
* Recently started on anti-depressant medications (past one month for those on Selective Serotonin Reuptake Inhibitors \[SSRI\] and past two months for those started on Monoamine Oxidase Inhibitors \[MAOI\])
Prognosis and Influencing Factors of Asthma in Children Aged 5-12 Years

The goal of this observational study is to 1)analyze the basic information of confirmed cases of asthma in children aged 5-12 years old hospitalized in the First Affiliated Hospital of Guangzhou Medical University from 2009 to 2020, 2)investigate the onset of asthma after 13 years old, 3)conducte lung function, blood and airway inflammation indicators, blood IL13 and IL1RL1 levels, 4)analyze the prognosis and influencing factors of children with asthma in this age group.Participants will be asked to fill a case report form and questionnaires. Besides, they should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Research methods:

Part I: Retrospective analysis of hospitalized cases of asthma in children aged 5-12 years old from 2009 to 2020: (1) General information of the children (gender, age and BMI); (2) Special medical history of parents; (3) The history of respiratory virus infection in the early life; (4) that age of the first occurrence of asthma; (5) The number of wheezes in the 12 months before the diagnosis of asthma; (6) Specificity; (7) trigger factors of symptoms; (8) Time pattern of symptom manifestations; (9) Illness severity; (10) Airway inflammation pattern; (11) Baseline of lung function; (12) Anti-inflammatory treatment; (13) Reactions to drug therapy. (14) coinfected diseases or complications. (15) Genetic information.

Part II: Patients who are lost to follow-up will be excluded. The patients will be divided into asthma relief group and asthma continuation group according to whether they had relapsed asthma after 13 years old. The case report form and C-ACT/ACT questionnaire will be filled out. Patients should provide examination results like lung function, total IgE, expired nitric oxide, blood and sputum granulocyte counts, and determination of blood IL13 and IL1RL1 levels over the past 6 months.

Part III: Univariate and multivariate analyses will be performed for different prognostic outcomes of asthma in children aged 5 to 12 years.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized children with asthma (age range 5-12 years old) from 2009 to 2020 in the First Affiliated Hospital of Guangzhou Medical University were collected. Diagnostic criteria were included by referring to global initiative for asthma and Guidelines for Diagnosis, Prevention and Treatment of Pediatric Bronchial Asthma revised in 2008.

Exclusion Criteria:

* Children who declined follow-up
* Children with pulmonary and tracheal dysplasia, bronchiolitis obliterans, and other conditions leading to wheezing
Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody \[cA2\]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.

This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..

Patients will be treated with either infliximab or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active Rheumatoid Arthritis despite treatment with methotrexate
* Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
* Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
* Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

* Patients having any systemic inflammatory condition
* Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
* Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
* Who have used corticosteroids within 4 weeks prior to screening
* Having received previous administration of infliximab