cyrilzakka/clinical-trials huggingface dataset:
Registry of Asthma Patients Initiating DUPIXENT®

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.

This includes characterization of:

* Patient demographics (eg, gender, age, and race)
* Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

* To characterize real-world use patterns of DUPIXENT® for asthma
* To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
* To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
* To collect long-term safety data on study participants in the real-world setting

3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to comply with the required clinic visits, study procedures and assessments
* Able to understand and complete study-related questionnaires
* Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
* Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information

Key Exclusion Criteria:

* Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
* Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

A randomized controlled study involving 300 patients with recurrent implantation failure

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ranged from 20-40 years.
2. Normal appearance of the uterine cavity on hysterosalpingography.
3. Patients prepared for IVF/ICSI cycle.

Exclusion Criteria:

1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
2. Patients with uterine cavity pathology previously known to the examiner.
3. Patients with previous uterine surgery such as myomectomy.
4. Patients with abnormal HSG.
Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.

Eligibility Criteria:
Inclusion Criteria:

* ≥21 years old
* Referred by the provider via Ask-Advise-Connect
* Receiving care at one of the participating clinics
* Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)
* No household members already enrolled

Exclusion Criteria:

* Unstable medical or psychiatric illness
Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention

This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.

The main complication of the transradial access is the occlusion of the radial artery, which although clinically silent in most cases, has been associated with critical hand ischemia, more importantly it limits the radial approach for future coronary interventions, and limits the use of this conduit for coronary revascularization surgery and arteriovenous fistulas.

Factors that prevent occlusion of the radial artery have been identified, including the use of several hemostatic techniques at the conclusion of cardiac catheterization.

The patent hemostasis defined as a technique that allows permeability of the radial artery and at the same time ensures the absence of bleeding was the first hemostatic method that showed a decrease in the incidence of radial artery occlusion, it is currently the quality standard for hemostasis in transradial access worldwide. Recently, the patent hemostasis plus ulnar compression was described, which proved in a randomized clinical trial to be superior to conventional patent haemostasis, decreasing the incidence of radial artery occlusion to 0.8% at 30 days. These hemostatic methods are a subject of current research worldwide. And more clinical trials are expected to confirm the superiority of patent hemostasis plus ulnar compression.

The hemostatic discs used at the beginning as an attempt to reduce the times for the hemostasis of the radial access and therefore the recovery times in units of high volume have attracted attention for their effectiveness and their low incidence of radial artery occlusion, there are few reports who place it as a potential strategy to reduce the incidence of radial artery occlusion. Its effectiveness should be validated in dedicated trials with an adequate sample size.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, both genders, in whom successful transradial access is obtained for elective and urgent diagnostic or therapeutic coronary procedures.

Exclusion Criteria:

* Patients over 18 years of age, both genders, in whom successful transradial access is not achieved and crossover is performed to femoral access.
* Patients over 18 years of age, both genders, who do not give their informed consent to participate in the study.
* Patients over 18 years, both genders, with cardiogenic shock.
EGM Analysis in Idiopathic Outflow Tract Ventricular Arrhythmia

Investigate the value of unipolar and bipolar electrograms (EGM) for predicting the successful ablation site for idiopathic outflow tract ventricular arrhythmia (OTVA).

The proposed study aims to evaluate the predictive value of using reversed polarity in adjacent bipolar EGMs (bi-RP method) and unipolar EGM with QS morphology (uni-QS method) for identifying successful ablation site, and evaluate the feasibility of enhancing uni-QS method's performance by using its morphology characteristics such as descending slope and symmetry.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo ablation for idiopathic OTVA
* Have the ability to provide informed consent for study participation.

Exclusion Criteria:

* Be currently participating in any other investigational study
* Be less than 18 years of age
* Be pregnant
* Has any other conditions that are not suitable for catheter ablation (including but are not limited to active whole-body infection or sepsis, coagulation or hemorrhage disorder history)
Evaluation of Ambulatory ECG Telemetry for the Early Detection of Atrial Fibrillation During Hospital Assessment of Cerebral Infarction

The aim of the study is to show that an ambulatory ECG telemetry monitoring of some patients hospitalized for cerebral infarction increases the frequency of the diagnosis of atrial fibrillation, cause of their stroke, and reinforces the protection against recurrences.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Diagnosis of transient ischemic or cerebral accident
* Absence of etiological orientation after the initial assessment (including at least cerebral MRI, angiography of the supra aortic trunks by CT or MRI, echocardiography with search for patent foramen ovale, standard biology)
* Affiliated to a social security system.
* Having given no opposition to participation in research

Exclusion Criteria:

* AF known or diagnosed during stay in USINV
Westlake N-of-1 Trials for Macronutrient Intake

This is a dietary intervention study in students and staff of Westlake University, which is designed to provide evidence in support of N-of-1 methods as an approach to advance personalized nutrition. The primary aim is using a series of N-of-1 trials to determine the impacts of a high fat, low carbohydrate diet (HF-LC) on glucose metabolism and gut microbiota in subjects versus a low fat, high carbohydrate diet (LF-HC) at both the individual and group level.

This study will employ a series of individual N-of-1 trials comparing a high fat, low carbohydrate diet (HF-LC) to a low fat, high carbohydrate diet (LF-HC). Participants will enter the study on a usual diet and will have a 6-day run in period for diet planning and baseline data collection before beginning their intervention. The HF-LC or the LF-HC will be randomized as the starting intervention followed by a wash-out period lasting for 6 days with normal diet between two interventions to eliminate previous intervention effects. Then the participants will be provided with the other diet. Both HF-LC and LF-HC last for 6 days in each set which consists of two wash-out periods and two intervention periods. There will be 3 sets in this study and investigators will aggregate the results of the completed N-of-1 trials across all participants to estimate the group level impacts of HF-LC compared to LF-HC.

Eligibility Criteria:
Inclusion Criteria:

* Willingness and capability to complete the study protocol

Exclusion Criteria:

* Inability or unwillingness to approved to provide informed consent
* Neurological conditions that might affect the assessment of the study measurement
* Hospitalization or surgery planned within 3 months
* Gastrointestinal diseases
* Other serious medical conditions, such as liver, kidney, or systemic disease
* Women who are pregnant or lactating
* Tobacco, alcohol, or illicit drug abuse
* Had taken antibiotics in the past two weeks prior to the start of the trial
* Participants on a vegan diet
* Any food allergy
* Lack of smart phone and data plan for participating caregiver
* Non-Chinese speaking participants
* Participating in another concurrent intervention study
Water Exercise and Health (WATHEALTH)

Aquatic cycling is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate effect of water temperature on energetic response (energy expenditure and food intake) of cycling exercise in water in normal weight and overweight premenopausal women.

After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.

Control session (CON): subject will stand sited without any activity during 40 min.

Subjects will be submitted to three aquatic cycling exercise session:

* session 27°C :aquatic cycling at 27°C without water jet during 40 min
* session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
* session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 20 and 40 years
* BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
* Daily breakfast
* Subject which approved informed consent
* Subject with French medical affiliation

Exclusion Criteria:

* Specific medical treatment
* Aquaphobia
* Subject under specific diet regimen or weight loss program
* Subject with cardio-vascular disease
* Surgical intervention less than 3 months
* Subject refusing informed and written consent
* Subject without French medical affiliation
* subject refusing inscription to the national voluntary list
* subject being in an exclusion period
* subject smoking or drinking alcohol frequently
* subject with intense physical activity
Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.

Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis
* Use of concomitant methotrexate

Exclusion Criteria:

* Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
* Serious medical conditions that would preclude the use of the treating agent
Green Light Effects on Anxiety

The main goal of this study is to determine whether exposure to a narrow band of green light (NBGL) improves outcome of psychotherapy sessions for the treatment of anxiety.

This is a within-subject study design that examines NBGL effects (as compared to white light) on anxiety level and treatment success, as evaluated by the treating psychotherapist and the patient. For each participant, the study will consist of 8 therapy sessions, each lasting 60 minutes, in which light conditions will be presented in the following order

Session 1: White light, Session 2: white light, Session 3: NBGL (i.e., green light), Session 4: NBGL, Session 5: NBGL, Session 6: NBGL, Session 7: White light, Session 8: White light

Effects of lights (white vs.NBGL) on anxiety level will be evaluated at the beginning and end of each therapy session by the patient, using a validated questionnaire. At the end of each session, the treating psychotherapist will fill another evaluation form that summarizes her/his impression of the treatment success or lack of.

Each patient is treated once a week and thus, study participation time is expected to last 8 weeks. Patients will self evaluate their anxiety level at the beginning and end of each of the 8 therapy sessions by completing the 20-questions State-Trait Anxiety Inventory (STAI Form Y-1).

Therapists will fill the following form after each of the 8 sessions:

Did you feel any difference while working with the patient in the green light as compared to regular room light?

Check all that apply:

* I was more focused
* I was more relaxed
* The patient was more relaxed
* The patient was more engaged
* The patient seemed more open
* The therapy progressed further

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of anxiety
* Being a patient at the Delray Center
* Older than 18 and younger than 95
* Being able to communicate in English
* Willingness to sign informed consent

Exclusion Criteria:

* Co-morbid psychiatric conditions
Escitalopram for the Treatment of Self-Injurious Skin Picking

The purpose of this study is to determine the effectiveness of escitalopram in treating self-injurious skin picking.

Purpose: Self-injurious skin picking is a problem documented to occur in 2 % of dermatology patients (Gupta, Gupta and Haberman, 1986) , and approximately 4% of the general population (Keuthen et al., 2000). It is widely under recognized, with medical sequelae that can include scarring, infections, lesions, and potentially life-threatening outcomes (O'Sullivan et al., 1999). In a prior study, fluoxetine was shown to be superior to placebo in treating self-injurious skin picking in a modest-sized double blind trial (Simeon et al., 1997). Similarly, open-label trials of other SSRIs, including sertraline (Kalivas, Kalivas and Gilman, 1996) and fluvoxamine (Arnold et al., 1999) resulted in reductions in skin-picking behavior. Escitalopram is a new SSRI that may have superior efficacy for the treatment of major depression and fewer side effects than other SSRIs. This study aims to assess the efficacy of escitalopram in patients who suffer from self-injurious skin-picking.

Comparisons: Subjects' initial scores on the CGI, HAM-D, SPTS, SPS, SPIS, BDI, BAI, QLESQ, \& BDDQ will be compared to subjects' final scores.

Eligibility Criteria:
Inclusion Criteria:

* Repetitive skin picking resulting in noticeable tissue damage and associated emotional distress and/or functional impairment.
* Age 18-65 years old.
* Duration of skin picking symptoms ≥ 6 months.
* MGH Skin Picking Scale score ≥ 10.
* Written informed consent.
* Females of childbearing potential must have a negative serum or urinary beta-HCG test and be willing to use acceptable methods of birth control during study tenure.

Exclusion Criteria:

* Pregnant women or females of childbearing potential who do not consent to use of a medically acceptable method of contraception.
* Women who are breastfeeding.
* Subjects who pose a serious suicidal or homicidal risk in the judgment of study investigators.
* Serious or unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease.
* Subjects with a dermatologic disorder that causes pruritis.
* Patients on anticoagulant therapy.
* History of seizure disorder.
* Comorbid bipolar disorder, psychosis, organic mental disorder, borderline personality disorder or developmental disorder. Subjects with obsessive compulsive disorder (with primary symptoms other than compulsive skin picking).
* History of substance dependence. If there is a history of substance abuse, subjects should be in remission for ≥ 6 months.
* Current treatment with cognitive behavioral therapy for skin picking.
* Current use of another SSRI medication.
* Other medications for medical disorders that might interfere with escitalopram.
* Current major depression or prescribed an antidepressant for major depression within the past 12 months.
* More than 1 adequate trial (at least 10 weeks at maximally tolerated dose) with another prior SSRI.
Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.

OBJECTIVES:

Primary

* Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs tamoxifen citrate.

Secondary

* Compare the response after 4 months of therapy.
* Define the resistant forms of cancer in patients treated with these regimens.
* Define the molecular signature predictive of sensitivity or resistance to ER+ breast adenocarcinoma by gene and serum protein profiling.
* Search for serum protein profiles predictive of recurrence-free interval.

OUTLINE: Patients are randomized into 1 of 2 intervention arms.

* Arm I: Patients receive oral letrozole once daily for 16 weeks.
* Arm II: Patients receive oral tamoxifen citrate once daily for 16 weeks. Patients in both arms then undergo surgery.

Blood and tumor tissue samples are collected at baseline and after completion of neoadjuvant therapy for changes in Ki67 and PCNA and serum protein profiling analysis.

After completion of study therapy, patients are followed up every 6 months for 3 years, and then once a year for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast adenocarcinoma

  * Clinically T2 tumor and/or \> 1 cm by echography
  * Estrogen receptor (ER)-positive and \> 10% of the tumor cells positive

    * No ER-negative disease
* No prior breast cancer
* No metastatic or inflammatory breast adenocarcinoma

PATIENT CHARACTERISTICS:

* Postmenopausal
* No cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
* No prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
* No mental incapacitation that would preclude consent
* No contraindication to tamoxifen citrate or letrozole

PRIOR CONCURRENT THERAPY:

* More than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
* No concurrent therapy that would modify the expression of the genes regulated by estrogen
* No concurrent participation in another clinical study