cyrilzakka/clinical-trials huggingface dataset:
Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation

Investigator study the efficacy and safety outcomes of Dapagliflozin use among newly diagnosed Atrial fibrillation patients when underwent rhythm control strategy regardless their diabetic status.

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure (HF) and mortality .

Based on the EAST-AFNET 4 trial and nationwide cohort studies, early rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation A new oral hypoglycemic drug, dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), was confirmed to reduce the risk of cardiovascular adverse events (AEs) and improve coronary heart disease and HF outcomes in multiple clinical trials . In addition, previous post hoc analyses and meta-analyses reported that dapagliflozin can decrease the incidence rate of new-onset AF Recent trials and meta-analyses have reported that SGLT2i can achieve greater suppression of AF recurrence after catheter ablation (CA) in T2DM patients . Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF among newly diagnosed AF patients who underwent rhythm control strategy regardless the diabetic status.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AF patients (Time between AF diagnosis to rhythm control attempt less than one year) Paroxysmal and persistent atrial fibrillation (AF) documented on a 12 lead ECG, Holter monitor (episodes of AF must be \>30 seconds in duration to qualify as an inclusion criterion) Age of 18 years or older on the date of consent. Informed Consent

Exclusion Criteria:

* Long standing persistent AF. Previous use of dapagliflozin within one month of rhythm control attempt. Previous rhythm control attempt. AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery). History of congestive heart failure. Active intracardiac thrombus Pre-existing pulmonary vein stenosis or pulmonary vein stent Contraindication to anticoagulation or radio contrast materials
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components

This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
* Those who have given their written consent for the study.

Exclusion Criteria:

* Patients of other forms of hypertension (other than primary)
* Those who have consistently BP \> /=180/120mmHg
* Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
* Patients of diabetes requiring insulin,asthma and kidney diseases.
Oral Health Among Children

The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.

This study could justify the implementation of public health actions in terms of prevention.


Eligibility Criteria:
Inclusion criteria:

- All children of classrooms selectionned

Exclusion criteria:

- Children absent on the day of the intervention
MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.

MeFirst is the first web-based, online, educational tool designed to promote Human Papillomavirus (HPV) vaccine awareness and understanding in an effort to improve HPV vaccine intent and uptake among female university students. HPV is the most common sexually transmitted infection and causes genital warts and cancer. The HPV vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. Tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. The proposed study is a randomized controlled trial testing the efficacy of the MeFirst tool vs. standard static educational material on increasing HPV vaccination intent and uptake among female university students aged 18-26.

Eligibility Criteria:
Inclusion Criteria:

* enrolled at the University of Michigan

Exclusion Criteria:

* receipt of any doses of HPV vaccine
Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients

This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.


Eligibility Criteria:
Inclusion Criteria:

1. Stable on dialysis for at least 3 months
2. Able to obtain informed consent
3. Medically stable
4. Dialysis adequacy at target for small solute clearance (ie Kt/V\>1.2 or Urea reduction ratio\>65%)
5. Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline

Exclusion Criteria:

1. Limb Amputation
2. Impaired cognition
3. Impaired vision
4. Haemoglobin concentration \< 110g/L
5. Change in Erythropoiesis stimulating agent dose over the last 2 months
6. Unable or unwilling to comply with exercise program
Postoperative Cyclic Oral Contraceptive Use for the Prevention of Endometrioma Recurrence

Ovarian endometriotic cyst (endometrioma) is one of the most common endometriotic lesions, and conservative laparoscopic surgery is the treatment of choice. However, the recurrence after surgery is common.

As repetitive surgery leads to morbidities and ovarian function decrease, recurrence after surgery frustrates both patients and clinicians. In this aspect, medical treatments have been offered after surgery to prevent or delay the recurrence. Gonadotropin-releasing hormone agonist (GnRHa) is frequently used in women with advanced endometriosis, but the efficacy is rather controversial. On the other hand, it has been demonstrated that oral contraceptives (OCs) could reduce or delay endometrioma recurrence, but data are still limited. Consequently, no one type of postoperative medical therapy has been shown to be superior in reducing the recurrence of endometrioma.

The rationale of postoperative medical therapy is that it could eradicate microscopic lesions which were not found and not treated sufficiently during surgery. Therefore, the maintenance of strongly suppressed condition induced by postoperative GnRHa treatment by addition of OCs could be a promising treatment to prevent the recurrence, but it has not been widely investigated.

We performed this retrospective cohort study to evaluate the efficacy of cyclic monophasic low-dose OCs as a maintenance therapy after GnRHa treatment for the suppression of endometrioma recurrence.


Eligibility Criteria:
Inclusion Criteria:

1. reproductive aged women who underwent conservative laparoscopic ovarian surgery for endometrioma (ASRM stage III/IV) which was confirmed by pathologic inspection
2. women who were given postoperative GnRHa injections every 28 days for 3 or 6 months
3. women with no residual lesion confirmed by ultrasonography after surgery
4. women who were followed up for over 12 months after surgery.

Exclusion Criteria:if they had

1. undergone hysterectomy during an operation
2. been given GnRHa injections more than 6 times
3. been given other types of postoperative treatment (progestin or intrauterine device)
4. a history of previous pelvic surgery for endometriosis
5. a history of hormonal treatment before surgery
6. been diagnosed as menopause after surgery
7. contraindications to OCs
8. been identified ovarian endometriomas within 6 months of postoperative evaluation
The Physiotherapy and Rehabilitation in Calfan Syndrome

Calfan syndrome is a progressive neurodegenerative systemic disease. It is a rare and difficult disease to diagnose due to the complex symptoms that occur over the years to postpartum. The aim of this study is to investigate the effectiveness of the physiotherapy and rehabilitation program in a rare case with Calfan syndrome.

13 years old, a female patient was diagnosed with Calfan syndrome one year ago. Only 11 patients have been identified in the literature. Its phenotype is characterized by recurrent episodes of liver failure and hepatic fibrosis in early childhood. Our patient had neurological symptoms that were gait disturbances, ataxia and tremor, as well as peripheral neuropathy and cognitive impairment. Also, musculoskeletal problems such as scoliosis, hip dysplasia, osteoporosis, thoracic kyphosis, and increased lordosis were observed.

Eligibility Criteria:
Inclusion Criteria:

* Calfan syndrome

Exclusion Criteria:

* Any surgery in past six months
Ablation of Consecutive Atrial Tachycardia

Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery
* Surface ECG-documentation of AT as primary clinical arrhythmia
* ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length ≥ 200ms

Exclusion Criteria:

* \< 18 years
* No previous atrial fibrillation ablation procedure or cardiac surgery
* Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
* History of hemorrhagic diathesis or other coagulopathies
* Contraindications for oral anticoagulation
* Hyper- or hypothyroidism
* Has any condition that would make participation not be in the best interest of the subject
Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients

The aim of this study is to evaluate the effects of a three-week inpatient pulmonary rehabilitation (PR) program on the walking speed in patients with chronic obstructive (COPD) or interstitial lung disease (ILD).

At most german traffic light crossings, a walking speed of 1,2m/sec is required to cross the road in time. Patients who are unable to cross the road at this speed, expose themselves to an increased level of stress and possibly the risk of accidents. Thus, they are discouraged from participating in an active social life.

An UK study (Nolan et al., Thorax 2018) showed that only 10.7% of the 926 patients with moderate COPD attained a walking speed of 1.2m/sec. As PR plays a key role in the management of chronic lung diseases in order to improve patients´ exercise capacity, the aim of this study was to evaluate the PR effects on the Walking Speed in patients with COPD or ILD. The investigators hypothesize that PR improves the ability to cross the road in the appropriate time.

Eligibility Criteria:
Inclusion Criteria:

* Participation in a pulmonary Rehabilitation program (Schön Klinik BGL)
* Indication: COPD or ILD
* COPD; FEV1 \<50%
* ILD: FVC \<70%
* written informed consent

Exclusion Criteria:

* non compliance
Integrating a Suite of Mental Health Apps for Depression in a Healthcare Setting

The purpose of this study is to evaluate the implementation of IntelliCare as a frontline intervention within health care settings.

This study will evaluate the implementation of IntelliCare in two settings: Primary care in the McLeod Health system, serving a rural population where mental healthcare workers are scarce, and Northwestern Medicine's Department of Psychiatry, which currently has a 9-month waitlist for psychological services.

Eligibility Criteria:
Inclusion Criteria:

* Patient who have been identified as depressed or anxious by a care provider in one of the participating healthcare organizations.

Exclusion Criteria:

* None
Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults

The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery.

Second purpose : to define apparent diffusion coefficient value of the bone sarcoma.

Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Ewing or Osteosarcoma, proven by biopsy and histopathology
* all patients are treated by chemotherapy defined by EURAMOS and EURO-EWING protocol

Exclusion Criteria:

* Patients under the age of 6 years old
* patients with contra-indication for MR exam (pace-maker...)
* Patients with renal insufficiency
* Claustrophobia
Correlation Between Exercise and Insulin Dose in a Camp for Pediatric Type 1 Patients

Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity.

The investigators want to evaluate steps, energy expenditure, sleep time and glycemic control and insulin dosage, through use of a wrist accelerometer, in pediatric type 1 patients attending a camp. Finding a correlation between these parameters could be useful not only for educational purposes but also in the development of algorithms for artificial pancreas.

Background and Aims Intense exercise is a major challenge to the management of type 1 diabetes. The management is even more difficult, during a camp, probably due to increased hypoglycemia maybe from increase of intensity of physical activity. Few studies confirm this hypothesis but none evaluated the correlation between steps, energy expenditure, sleep time and glycemic control and insulin dosage.

Methods and Materials 60 patients with type 1 diabetes, aged 10 to 12 years, in multiinjection insulin therapy observed for 21 days (one week of camp, one week before and one after it). Food program was the same both at home and during the camp. They checked glycemia almost 5 times a day. A wrist accelerometer was used to evaluate sleep, steps and energy expenditure.

All data were recorded in a daily diary.

Eligibility Criteria:
Inclusion Criteria:

* diabetes onset \> 1 year, multiple injection insulin therapy

Exclusion Criteria:

* Physical impossibility to movement, food allergy
Feasibility Study for Online Mindfulness for GAD

Method: . Forty patients with general anxiety disorder will be randomized in 1:1 ratio to the online resource plus usual care, and to usual care control group by stratified block randomization. Measurements including 7-item Generalized Anxiety Disorder questionnaire, 9-item Patient Health Questionnaire, Penn State Worry questionnaire, and Five Facet Mindfulness Questionnaire will be made at baseline and at 2-month. Rate of recruitment, drop out and website usage will be collected. All patients in the intervention arm will be interviewed to assess the clarity of the app and user experience. The scores between the two arms will be compared by t-test and the transcripts of the patient interviews will be analysed using thematic analysis


Eligibility Criteria:
Inclusion Criteria:

* received a diagnosis of GAD in the computerized record system (CMS) in Hong Kong hospital authority
* score ≥10 on the 7-item Generalized Anxiety Disorder scale (GAD-7), signifying active moderate anxiety symptoms
* used any website in prior 12 months
* received stable dose of psychoactive medications in last 2 months

Exclusion Criteria:

* any diagnosed psychotic disorder
* diagnosis of dementia
* any diagnosed substance abuse disorder (except smoking)
* active suicidal ideation (score ≥1 on 9-item Patient Health Questionnaire
* had regular mindfulness meditation practice in last 6 months or had participated in MBSR/MBCT course
Increased Lung Volume as Controller Therapy for Asthma

This is an early phase clinical trial to test the efficacy of elevating lung volume with positive expiratory pressure (CPAP) as a controller therapy for asthma in patients with a BMI ≥ 30 kg/m2.

There will be two phases to this trial.

Phase I:

In the first phase we will determine the optimal duration of CPAP that is effective as a controller therapy in asthma. Up to 9 participants will complete this this phase.

Phase II:

The 2nd phase will be a randomized double-blinded controlled trial of Sham CPAP versus CPAP 10 (using the duration of CPAP determined in phase I) as a controller therapy for asthma, and also to determine the effect o airway reactivity in healthy people with a BMI 30 kg/m2 and above. Twenty people with asthma and twenty controls will complete this phase.

The effect of 10 versus 0 cmH2O CPAP on airways responsiveness to inhaled methacholine will be studied using an adaptive "3+3" phase I/II study design.

Dose Titration Phase (phase I):

The efficacy of 8 hours of CPAP on airway responsiveness will be tested in three subjects.

Efficacy will be defined as a 25% improvement in the impedance response to methacholine in all three subjects. If this occurs in all subjects, shorter durations of CPAP will be studied (4 hours then one hour).

Conversely, if "dose escalation" is required, 3 nights, then 7 nights of CPAP will be studied.

Randomized-controlled study phase (phase II):

Participants will be randomized to CPAP 10 or Sham 0. The duration of CPAP will be determined in the dose titration phase. The effect on response to inhaled methacholine, lung function and asthma control will be determined in patients with asthma and a BMI ≥ 30 kg/m2, and also in healthy controls without asthma

Eligibility Criteria:
Inclusion Criteria for people with asthma:

1. Physician diagnosis of asthma
2. PC20 to methacholine \< 16 mg/ml
3. IgE \< 100 IU/ml
4. Ages 18-65 years
5. BMI \>=30 kg/m2

Inclusion Criteria for controls:

1. No physician diagnosis of asthma
2. PC20 to methacholine \> 16 mg/ml
3. IgE \< 100 IU/ml
4. Ages 18-65 years
5. BMI \>=30 kg/m2

Exclusion Criteria:

1. FEV1 \< 60 % predicted
2. Other significant disease that in the opinion of the investigator would interfere with study.
3. Inability to perform required testing.
4. Smoking within last 6 months.
5. ≥ 20 pack year smoking history
6. Inability to provide informed consent
7. Pregnancy
8. Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea
9. Asthma exacerbation in the prior 6 weeks
10. Stoke or heart attack in the prior 3 months
11. Known aortic aneurysm
12. Renal failure
13. A known severe heart, vascular, liver, renal, or hematological disease
14. Active allergic rhinitis
15. Recent eye surgery (within the last month)
Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803

RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.

OBJECTIVES:

* To determine the association between polymorphisms in drug metabolizing enzymes and lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent prostate cancer receiving lapatinib ditosylate on clinical trial ECOG-E5803.
* To determine the association between mutations in EGFR, HER-2 and Kras; protein expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and progression-free survival.

OUTLINE: Tissue and blood samples collected from patients enrolled on clinical trial ECOG-E5803 are analyzed for correlative studies. Samples are assessed for HER2, EGFR, MAPK, and Akt; EGFR mutations and polymorphisms in CYP3A4; Ras mutations; recently identified mutations in HER2-neu and Kras; and additional polymorphisms in the lapatinib ditosylate metabolic pathway by automated quantitative IHC. Predictors of efficacy and toxicity are analyzed, including markers in the EGFR pathway as predictors of progression-free survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer

  * Recurrent disease
* Received lapatinib ditosylate on clinical trial ECOG-E5803

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics