cyrilzakka/clinical-trials huggingface dataset:
Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution

Inhaled tobramycin is a Cystic Fibrosis Foundation recommended effective treatment for individuals with cystic fibrosis for the management of Pseudomonas aeruginosa airway colonization and improves the FEV1 and reduces the number of acute pulmonary exacerbations of CF. Patients typically use the inhaled tobramycin for a period of 28 days. Unfortunately, the standard nebulizer method for delivering tobramycin inhaled solution (TIS) is time-consuming and may result in missed therapy doses and suboptimal care. A new inhaled formulation and delivery device, the TOBI Podhaler (TPI), an alternative method of administering inhaled Tobramycin will be used and assessed. This new pocket-sized disposable inhaler is maintenance-free, requires no refrigeration or power source, and should greatly increase patient mobility and improve time management.

Adult cystic fibrosis patients from the Rush University Medical Center Adult Cystic Fibrosis Program will be recruited for a prospective before and after cohort study to evaluate patient preference for either the TOBI Podhaler or inhaled tobramycin solution and compare the efficacy of the TOBI Podhaler to tobramycin inhaled solution. This project will evaluate the potential differences in efficacy, medication adherence, treatment time, side effects/adverse effects, quality of life, and identify patient preferences between the use of TIP and TIS. Measurements after a 28-day cycle of tobramycin inhaled solution, first 28-day cycle of TOBI Podhaler and third 28-day cycle of TOBI Podhaler will include FEV1, number of acute pulmonary exacerbations, adherence, cough frequency, sputum characteristics, and side effects or adverse events. The quality of life as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be measured after a 28-day cycle of tobramycin inhaled solution and the third 28-day cycle of TOBI Podhaler. The FEV1 values, number of missed treatments, and total treatment time will be analyzed through a repeated measures analysis of variance. Comparisons of the CFQ-R data before and after the switch to the TPI will be made with the Student's t-test.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years) diagnosed with cystic fibrosis
2. Airway colonization with Pseudomonas aeruginosa that is sensitive to tobramycin in vitro and currently managed with Tobramycin inhaled solution who are interested in switching to the TOBI Podhaler.

Exclusion Criteria:

1. Persons unable to communicate in English,
2. Pregnant patients,
3. Patients \< 18 years of age
Text 2 Connect- Texting Intervention for Mental Health Treatment Utilization

Text2Connect (T2C) proposes to test a text-based intervention designed to improve engagement with mental health treatment.

To enhance outcomes for transition-age youth with mental health disorders during the vulnerable period that occurs during their first several months of college, the investigators propose an automated TM intervention, "Text to Connect" (T2C), that aims to increase mental health self-efficacy through psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.

Assignment of Interventions:

The study will utilize block randomization whereby 2/3 of participants will be randomly assigned to receive T2C, and 1/3 to receive PE. Blocks will balance the groups on site (CCP versus STAR/CABS). A 2:1 randomization scheme will randomize 50 youth to either receive T2C (n=30) or a link to brief psychoeducational videos about mental health (PE; n=20). All participants will then complete a brief battery of self-report assessments online at baseline and again monthly through month 4. Youth randomized to receive PE will receive a text message with the link to the webpage with the psychoeducational videos. Youth randomized to receive T2C will be onboarded and initiate the TM intervention that sends automated prompts at minimum monthly through month 4.

Hypothesis:

Aim 1. To examine the feasibility of T2C for transition-age youth with psychiatric disorders (n=3 clinics, 50 adolescents). Youth randomized to receive T2C will:

Hypothesis 1a. engage with T2C at high rates (\>70% response rate to SMS prompts).

Hypothesis 1b. report high levels of satisfaction (\>70% satisfaction) and usability with T2C.

Aim 2. To examine the impact of T2C versus PE on mental health self-efficacy, symptoms and functioning, and treatment engagement. Over 4 months, youth who receive T2C, as compared with youth who receive PE, will report:

Hypothesis 2a (Primary). Greater mental health self-efficacy Hypothesis 2b (Secondary). Lower symptom severity and greater psychosocial functioning Hypothesis 2c (Secondary). Higher rates of follow-through with mental health services

Eligibility Criteria:
Inclusion Criteria:

* Participant engaged in treatment at CC Waterdam, STAR or CABS clinic
* Participants have a current psychiatric diagnosis documented in their electronic medical record and/or be in receipt of mental health services within 3 months per self-/ parent- or clinician- report
* At least 18 years of age
* Recently graduated high school
* Planning to attend college or higher education program within 6 weeks
* Own a text-capable phone
* Be willing and able to provide informed consent

Exclusion Criteria:

* Participants will be excluded if they have conditions that might impair their ability to effectively engage in Text2Connect
* Under the age of 18yo
* Non-English speakers
Bioequivalency Study of 300 mg Lithium Carbonate Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane lithium carbonate 300 mg extended release tablet formulation compared to Solvay's Lithobid 300 mg extended release tablet under fed conditions using a single-dose, randomized, 2 treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to lithium, or any comparable or similar product.
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.

The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).

The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.

This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass.

Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed
* 4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus .
* SLEDAI \< 8 at Screening and at Baseline
* Stable immunosuppressive dose prior to randomization.
* Body Mass Index \< 30
* Able to swallow pills at randomization

Exclusion Criteria:

* Refuse of the patient or the legal responsible
* Use of vitamin D2 or D3 supplementation
* Significant renal insufficiency
* Primary hyperparathyroidism (known)
* History of nephrolithiasis (known)
* Diabetes mellitus requiring insulin therapy
* History of vertebral compression fractures (known)
* Pregnancy
* Use of bisphosphonates
Regional Anesthesia in Total Hip and Knee Arthroplasty

The purpose of this study is to test whether the use of Ropivacaine and Mepivacaine are better in terms of effectiveness, cost, and safety than Bupivacaine as regional anesthetics in elective hip or knee replacement surgery.

Advances in pain management, regional anesthesia, and focused rehabilitation have increased the popularity of outpatient total hip and knee arthroplasty in a select group of eligible patients. However, one of the main impediments to same-day discharge is the prolonged motor block post-spinal anesthesia, as patients are routinely kept in the post-anesthesia care unit (PACU) until they demonstrate that the spinal anesthesia has worn off.

At The Ottawa Hospital, the standard treatment for people receiving anesthesia during a total arthroplasty is the use of the anaesthetic, Bupivacaine. Mepivacaine and Ropivacaine are alternative anaesthetics that are also in use at The Ottawa Hospital. They are growing in popularity as anaesthetics because they and allow quicker recovery time when compared to Bupivacaine. Bupivacaine results in a long-lasting sensory-motor block, meaning that in the area that the local anesthesia was used, there is no sensation and limited movement for long periods of time. During hip or knee replacement surgery, you may want to have no sensation and the inability to move your lower limbs. However, it is not ideal for after surgery where weakness in the legs puts a person at increased risk for falls. Therefore, hospitalization after surgery typically lasts for a longer duration. Mepivacaine and Ropivacaine have a shorter motor block duration, allowing for a potentially earlier hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total hip or knee replacement

Exclusion Criteria:

* Study refusal
* Inability to provide consent
* Contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis)
* Bilateral surgery
* Revision surgery
* Pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent
* Pregnancy
* Not receiving preoperative adductor canal block for any reason
* Contra-indication to multimodal analgesia (acetaminophen or NSAIDs)
* Obstructive sleep apnea requiring extended PACU stay
* History of severe postoperative nausea and vomiting
Fulvestrant 500mg With Exemestane Endocrine Therapy for Postmenopausal Advanced Breast Cancer Patients

A Randomized, Open label, Parallel-group, Multi-center study. Eligible patients will be randomized in a 1:1 ratio to receive fulvestrant 500 mg or Exemestane 25mg.

To compare the efficacy and tolerability of Fulvestrant 500 mg with Exemestane 25 mg as first line endocrine therapy in postmenopausal women with oestrogen receptor positive HER2 negative advanced breast cancer who have relapsed on or after adjuvant non-aromatase inhibitor therapy

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent document on file;
* Age over 60 years;
* Age \< 60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol level in the postmenopausal range;
* Patients with metastatic or locally advanced disease not amenable to therapy with Curative intent
* ER + and/or PgR +;
* Duration of adjuvant non-aromatase inhibitors treatment should be at least 2 years or more;
* WHO performance status 0, 1 or 2;
* Patients with life expectancy of more than 3 months.

Exclusion Criteria:

* Presence of life-threatening metastatic visceral disease;
* Previous systemic chemotherapy for advanced breast cancer;
* Received systemic endocrine therapy for advanced disease;
* Extensive radiation therapy within the last 4 weeks ;
* Platelets \< 100\*109 / L,Total bilirubin no less than 1.5ULRR, ALT or AST no less than 2.5ULRR if no demonstrable liver metastases or no less than 5ULRR in presence of liver metastases;
* Severe renal impairment, bleeding diathesis, long-term anticoagulant therapy;
* History of hypersensitivity to active or inactive excipients of fulvestrant, Exemestane and/or castor oil.
The Recovery of Cardiovascular Patients With Depression

Cardiovascular disease increases the risk of depression and vice versa. Many cardiovascular patients are subjected to percutaneous coronary intervention (PCI). Potential biomarkers for the development, the course and the recovery of both diseases are in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons.

The aim of the study is to detect the depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery and on the changes of BDNF.

It has been shown that cardiovascular disease increases the risk of depression and vice versa. A significant proportion of cardiovascular diseases are coronary artery disease; most of these patients are subjected to percutaneous coronary intervention (PCI). That population of patients, which is under greater risk of depression, has been passing through the health system without adequate management of psychiatric difficulties. Despite the abundance of the data regarding the concomitancy of cardiovascular disease and depression, potential biomarkers for the development, the course and the recovery of both diseases are still in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons. Its' serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher risk of coronary incident in angina pectoris. BDNF is also reduced in depression, but increases during a pharmacological treatment along with the clinical improvement.

Therefore the aim of the study is to detect the occurrence of depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery of those patient and the correlation with the changes of serum levels of BDNF.

This represents the objectivization of the tertiary type of prevention intervention for recovery of cardiovascular patients who are currently passing through the investigator's health system with unrecognized psychiatric comorbidity.

Eligibility Criteria:
Inclusion Criteria:

* patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction
* without antidepressant drugs or major tranquilizers more than one year

Exclusion Criteria:

* symptoms of myocardial infarction lasting more than 12 hours
* left ventricle ejection function (LVEF) less than 40%
* earlier presence of cardiomyopathy
* acute infection
Omega-3 Fatty Acids Supplementation in ADHD

The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.


Eligibility Criteria:
Inclusion Criteria:

Participants between ages 6 and 12 years who:

1. have been clinically diagnosed with ADHD by a physician
2. meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
3. are willing to participate in a randomized, double-blind, placebo-controlled trial, complete with written, informed parental consent,
4. are on stable dosage of methylphenidate treatment before the start of the study
5. are able to speak English or German

Exclusion Criteria:

1. Participants who are younger than 6 years old or older than 12 years old
2. Those who have not been clinically diagnosed with ADHD by a physician
3. Those who did not meet the criteria of ADHD-Inattention, ADHD-Hyperactivity-Impulsivity, or ADHD-Combined type as determined by the SNAP-IV (Swanson, 1992)
4. Those without written parental consent
5. Those with brain pathology such as serious head injury, epilepsy, and intellectual disability (IQ \< 70)
6. Those with titrated dosage of methylphenidate before the start of the study
7. Those on neurofeedback training, and/or psychosocial intervention addressing attention problems
8. Those with known hypersensitivity to the IMP under investigation
9. Those who are unable to read and understand the parent/participant information
10. Those receiving medications other than methylphenidate
Systemic Redesign and Demonstration for Early Detection, Evaluation and Management of Chronic Kidney Disease in Shanghai

Based on clinical evidence based medicine and organizational management model, investigators redesign the prevention and treatment of chronic kidney disease of public health system in Shanghai China. The investigators hope to find early chronic kidney disease, prevention and clinical intervention of orderly combination. The advantages of this system were confirmed by comparing the prevalence rate, awareness rate and treatment rate before and after the completion of the system.

The whole study mainly includes the following parts:

1. Establishment of a database of patients with kidney disease, and training data entry specialist in every center.
2. Conduct propaganda of kidney disease knowledge, training professional doctors in center hospital and community hospital.
3. Search for high-risk patients, and screening for patients with kidney disease from community residents in community hospital.
4. Establishment of a standardized and orderly patient referral process from community hospital to center hospital or three level of first-class hospital.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Signed informed consent

Exclusion Criteria:

* Refused to accept the blood and urine test
AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.


Eligibility Criteria:
Inclusion Criteria:

* patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
* no prior therapy for metastatic disease

Exclusion Criteria:

* patients with locally advanced disease who are candidates for radiation therapy.
* uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Has had a self-reported oculo-visual examination in the last two years
* Is 50 years of age or greater and has full legal capacity to volunteer
* Is able to read and understand the informed consent
* Is willing and able to follow instructions and maintain the appointment schedule
* Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
* Near Add Power requirement of +2.25D or greater
* Has spectacle cylinder 0.75 D in both eyes
* Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
* Has clear corneas and no active ocular disease
* Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or abnormality that would affect the wearing of contact lenses
* Is aphakic (i.e. missing their natural lens inside their eye)
* Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study.
Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block

This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard indications
2. An ECG with a wide QRS complex (\>130 ms)
3. ECG morphology of typical complete LBBB,
4. Patients have heart failure with NYHA Class II-IV symptoms,
5. LV EF \<50%
6. At least 18 years old and not pregnant.
7. Must provide written informed consent prior to any clinical investigation related procedure.
8. Willing to comply with study evaluation requirements
9. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days prior to the implant procedure per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.)

Exclusion Criteria:

1. Patients have non-specific intraventricular conduction delay or right bundle branch block
2. Previously implanted cardiac devices with three or more permanent leads
3. History of aortic valve repair or replacement
4. History of tricuspid valve replacement
5. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
6. Recent (\< 3 months) myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacemaker or CRT implant in the opinion of the investigator
7. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.