cyrilzakka/clinical-trials huggingface dataset:
Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility

Traditional offline interventions such as MBCT and MBSR have been implemented to treat patients with emotional disorders and obtained significantly improved clinical outcomes. However, these offline interventions require the involvement of a therapist expert in mindfulness and usually charge a high fee, which may not be accessible and cost-effective for lots of patients with psychological disorders. Fortunately, online self-help interventions can compensate for these disadvantages. Our research team has developed a self-help online mindfulness program targeting emotional distress (i.e., iMIED), which has been effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffer from emotional distress, the current study will apply this program to these patients, and investigate its auxiliary effects on patients' psychological and physical health.

The primary aim of the current study is to evaluate the effectiveness of iMIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (iMIED) except for treatment as usual (TAU) will be compared with patients who receive TAU alone. We expect the intervention to improve patients' psychopathological symptoms reported by the patients and the clinicians or the research team and increase their overall functioning, positive mental health, and physical health compared to TAU. In addition, previous studies have shown that mindfulness interventions improve psychological symptoms by improving cognitive flexibility. Therefore, the secondary aim of the study is to examine the mediating effect of cognitive flexibility on the relationships between mindfulness practice and improvements in outcome variables, and further explore the mechanism behind it.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

Exclusion Criteria:

* Subjects who could not access the Internet;
* Subjects with insufficient Chinese ability;
* Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
* Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
* Subjects at risk of suicide.
Shockwave IVL + DCB

Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions.

This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:

   * De novo lesion with diameter stenosis \> 50% (visual analysis)
   * Coronary vessel diameter \< 3.0 mm (visual analysis)
   * Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstrated calcium angle of ≥270° on at least 1 cross section.
3. Written informed consent

Exclusion Criteria:

1. Previous coronary intervention at or \< 10 mm distant from target segment at any time.
2. Lesion length ≥ 40 mm.
3. Planned atherectomy or cutting/scoring balloon use.
4. Bifurcation lesion.
5. Thrombus containing lesion.
6. Life expectancy \< 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study
Post-Radioiodine Graves' Management: The PRAGMA-Study

Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Out-patients 18 years of age or over, who have given written informed consent to participate in the study
* Diagnosed with Graves' disease
* Received radioiodine for treatment of Graves' disease
* Had a minimum of 12 months follow-up after RI
* Most recent RI dose 5 years ago or less at the time of enrollment

Exclusion Criteria:

* Patients unable to give informed consent
* Age 17 years or younger
* Cause of thyrotoxicosis other than Graves' disease
* Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.
* Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
The Impact of Active Nurse Participation on Adenoma Detection During Routine Colonoscopy

Hypothesis-- Nurse observation in addition to the colonoscopist while withdrawing the colonoscope from the cecum leads to a greater adenoma detection rate.

Methods- Patients presenting for screening colonoscopy are randomized to nurse observation or usual practice. Risk factors for adenoma development and the adenoma detection rate in each group will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* performance of screening colonoscopy

Exclusion Criteria:

* history of inflammatory bowel disease, gastrointestinal bleeding
A Pilot Study to Evaluate a Method for Plaque When Comparing Stannous Fluoride Toothpaste to a Regular Dentifrice

This study will evaluate the sensitivity of an assay and its ability to split a marketed stannous fluoride toothpaste versus a negative control.


Eligibility Criteria:
Inclusion Criteria:

In order to be included in the study, each subject must:

* Provide written informed consent to participate in the study;
* Be 18 years of age or older;
* Agree not to participate in any other oral/dental product studies during the course of this study;
* Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
* Agree to maintain their current oral hygiene routine between the Screening and Baseline Visit and not to add/change their oral care products during this time;
* Agree to refrain from any form of non-specified oral hygiene during the treatment periods (after the Baseline Visit), including but not limited to the use of products such as floss or whitening products;
* Agree to return for all scheduled visits and follow study procedures;
* Must have at least 16 natural teeth;
* Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study;
* Agree to refrain from all oral hygiene for at least 12 hours prior to each visit;
* Agree to refrain from eating, chewing gum, drinking and using tobacco for 4 hours prior to each visit;
* Have at least 20 bleeding sites (sites with a score of 1 or 2 on the GBI index);
* Have minimum 3 sampling sites with bleeding and pocket depth ≥3mm but not deeper than 4mm;
* Have minimum 3 sampling sites without bleeding and with pocket depth ≤2mm.

Exclusion Criteria:

Subjects are excluded from study participation where there is evidence of:

* Have had a dental prophylaxis within 2 weeks of plaque sampling visits;
* Have taken antibiotics or used anti-gingivitis / anti-bacterial oral care products such as chlorhexidine or Listerine within 2 weeks of plaque sampling visits;
* Have rampant caries, open or untreated caries, or advanced periodontitis requiring prompt treatment;
* Need an antibiotic prophylaxis prior to dental visits;
* A history of hypersensitivity to oral care products containing hydrogen peroxide;
* A history of hypersensitivity to dyes (from products containing food dyes);
* Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study; or
* Are pregnant (Self-reported) or lactating.
Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections

This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.

Eligibility Criteria:
Inclusion Criteria:

* Met HLH-2004 diagnostic criteria;
* Active infection；
* Empirical treatment with carbapenems did not respond after 72 hours；
* Age \>18 years old, no gender limitation;
* Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

* Other antibiotics should be selected according to the results of drug sensitivity；
* Systemic antibiotics other than carbapenems are used with 72 hours；
* Inability to take oral medications due to disease of gastrointestinal tract；
* Severe liver insufficiency;
* Expected survival time \< 1 month;
* Pregnant or breasting-feeding women;
* Allergic to Carrimycin tablets;
* Active hepatitis B or hepatitis C infection;
* Patients with HIV infection;
* Patients with other contraindications considered unsuitable for participation in this study.
Clown Care for Botulinum Toxin (BTX)

Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.

PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys), enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per procedure). Prior to treatment each child was assigned to receive either medical clown intervention (study) or standard care (control). Outcome measure was the Visual Analogue Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each procedure.

Eligibility Criteria:
Inclusion Criteria:

* Children with CP for whom BTX treatment was indicated

Exclusion Criteria:

* Children with minimal communication skills (n =1)
* Autistic spectrum disorders (n =1)
* Severe anxiety requiring general anesthesia (n =1)
Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.

Eligibility Criteria:
Inclusion Criteria:

* Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD.
* Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent.
* Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome).
* Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort.

  * Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period.
  * Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period
* Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up.
* Permission to contact the participant's and her infant's HCPs.

Exclusion Criteria:

* If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study.
* Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes.
Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism

The goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. We have 2 specific aims:

* During the 2-year UG3 phase, we will use the Discover, Design+Build, and Test Framework to modify our existing app and pilot the intervention.
* During the 4-year UH3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes.

Participants will asked to use the app, complete surveys on REDCap, participate in feedback interviews and focus groups. Behavior change in the experimental group will be compared with that in the control group.

Adolescents with autism are at increased risk for tooth decay in part because of poor diet and toothbrushing habits. Effective ways to reduce added sugar intake have yet to be tested, but technologies exist to help improve toothbrushing. Mobile health apps are a promising but underutilized way to improve and enforce toothbrushing habits. Many adolescents with autism are enamored with technology and own devices that support apps. We propose a Stage II efficacy trial in modifying a toothbrushing app and inform behavior change in the target population.

Eligibility Criteria:
Inclusion Criteria:

* Child participants will have Autism Spectrum Disorder that will be confirmed by: (1) chart review by clinical staff at the recruitment sites to determine if the child meets the DSM-5 criteria for autism spectrum disorder; OR (2) affirmative caregiver response (YES) to the question, "Has a healthcare provider ever diagnosed your child with autism?"
* Willingness to take a CARS-2 \[Childhood Autism Rating Scale-2\], which will be administered by trained staff
* Child brushes independently \[The child needs to be able to hold the toothbrush and move it around their teeth, mostly unassisted\]
* Child uses touch screen devices (e.g.,smartphones or tablet)
* Ages 10 to 17 years at enrollment
* Caregiver and child able to communicate in English
* Caregiver age ≥18 years and able to provide informed consent in English
* Child and caregiver live in the same home
* Child has ready access to a mobile device with a front-facing camera onto which apps can be downloaded (iPad or iPhone with iOS 16.0+; Android tablet or phone with Android 13.0+)
* Family has a Wi-Fi or cellular data plan to allow app data to be transmitted, with confirmation of via tools like the Ookla Speed Test to help problem solve and ensure that app data can be transmitted

Exclusion Criteria:

• Children with autism younger than age 10 years will be excluded
Spinal Anesthesia Induced Hypotension During Cesarean Section

The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* Elective cesarean section
* Weight 50-120 kg, Height 150-180 cm
* Normal singleton pregnancy
* Beyond 36 weeks gestation
* No known fetal abnormalities
* Ages 18-35

Exclusion Criteria:

* Contraindications to spinal anesthesia
* Multiple gestation, placenta previa, accreta
* Pregnancy induced hypertension or preeclampsia
* Diabetes mellitus, cardiovascular diseases
* Coagulopathy
* Spinal cord abnormalities, spinal surgery, or preexisting neurological dysfunction
* Baseline HR \<65
* Failed spinal anesthesia/inadequate sensory block for surgery
* History of abnormal bleeding
* History of adverse reactions to hydroxyethylstarch
VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis (IA) in Adults

The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).

Eligibility Criteria:
Inclusion Criteria:

* Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA

Exclusion Criteria:

* Pregnant or breastfeeding
* IA involving sites other than lungs and sinuses
* Graft failure, acute or extensive chronic GvHD
* Uncontrolled diabetes
Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients

Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.

This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.

The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients for whom a tracheostomy is planned
* Patients on invasive ventilation for \>72 hours

Exclusion Criteria:

* Tracheostomy for upper airway obstruction or other disease
* Patients tracheostomized before current hospitalization
* Patients with Glasgow Coma Scale (GCS) \< 8/10 after cardiac arrest
* Patients with GCS \< 8/10 because of primary central neurologic disease
* Patients for whom therapeutic limitations have already been decided
* Patients for whom weaning from ventilation is not an objective
* Patients suffering from myasthenia gravis
* Patients with cardiac assistance device
* Patients with medullary lesion proximal to C5
* Patients for whom nasogastric tube insertion is contraindicated
AML Treatment in Untreated Adult Patients

The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to EORTC-GIMEMA AML10 study.

The post-remissional treatment is based on transplant with HLA compatible donor is foreseen for all patients and autologous transplant for those without HLA compatible donor available.

GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive consolidation with cytarabine (500 mg/m2/q12 hrs d1-d6) and the same anthracycline as in induction on d 4-6. Following consolidation, eligible pts (age \<45 or 55 yrs) with a HLA compatible sibling had to be allografted, the others, had to be autografted with autologous peripheral stem cell (PSC) collected during recovery from consolidation.

BM and PB samples at diagnosis were centralized according to a national GIMEMA original study planned with the aim to accurately evaluate biological characteristics at diagnosis and to identify genetic alterations with prognostic relevance and to follow up cases monitoring minimal disease during remission. To allow the adequate collection and sending of samples before starting intensive chemotherapy, all patients received a 5-day pretreatment consisting of hydroxiurea (HU) at the dosage of 2 g/m2/day, also effective for "debulkying" of disease.

Eligibility Criteria:
Inclusion Criteria:

* AML "de novo" with bone marrow blasts \<=30%
* Performance status: 0-3
* FAB subtype: all except M3
* Written informed consent

Exclusion Criteria:

* age \<15 years and \>= 61 years
* pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
* diagnosis of acute promyelocitic leukemia (M3)
* Performance status = 4
* Uncontrolled infection