cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which starts in childhood and is characterized by symptoms of attention deficit, hyperactivity and impulsivity. Persistence into adolescence is frequently associated with among other low educational achievement, interpersonal difficulties, anxious and depressive symptoms and sleep problems. Treatment guidelines recommend psychological treatment as part of the treatment plan, however compared to children and adults, there is still a substantial lack of knowledge about appropriate psychological treatment in adolescents. The present study examines a psychological intervention for adolescents with ADHD, cognitive behavior group therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions addressing core difficulties and concerns of the adolescent population with ADHD. The investigators wish to determine the efficacy of group therapy in adolescents with ADHD who receive medical treatment but still have impairing ADHD symptoms.

Change February 1st 2017: Inclusion of patients with mild to moderate behavioral problems in order to achieve enough participants in the study.

Change February 1st 2017: The study primarily recruits patients who are on pharmacological treatment for ADHD. However, for ethical reasons and in order to achieve enough participants, the study will also recruit patients who have not responded to at least two drug trials or have been unable to continue pharmacological treatment because of intolerable side effects.

Change February 1st 2018: The Weiss Functional Impairment Rating Scale, Rosenberg and BRIEF questionnaires will not be collected at the 9-month follow-up due to lack of resources (project assistance).

Eligibility Criteria:
Inclusion Criteria:

* Attention deficit hyperactivity disorder (ICD-10)
* Clinical Global Impression (CGI) \>=3
* Informed consent patient
* informed consent parents
* if on medication, dosage is stable since at least 2 months

Exclusion Criteria:

* mental retardation
* behavioral problems
* drug addiction
* psychosis
* suicidal
Is the Severity of Urinary Disorders Related to Falls in People With Multiple Sclerosis

Falls are a common problem in people with multiple sclerosis (PwMS) and can lead to severe consequences (trauma, fear of falling, reduction of social activities). Prevention of falls is one of the priority targets of rehabilitation for PwMS and walking difficulties, which can result of different factors (motor impairment, ataxia, sensitive disorders, fatigability...). Urinary incontinence has been evoked as predictive of falls. But lower urinary tract symptoms (LUTSs) are frequent in PwMS, the prevalence of LUTSs is high (32-96.8%) and increases with MS duration and severity of neurological deficiencies and disabilities. Overactive bladder (OAB) is the most common symptom. Despite its high prevalence and impact on quality of life, the severity of LUTSs has never been studied as specific risk factor of falling. However, urinary urgency and urinary incontinence could lead to precipitation and thus could increase the risk of falling in these patients.

The aim of the study was to assess the relationship between severity of LUTSs and risk of falling in PwMS.

Patients were asked about the number of falls in the past three months and in the past year, and the circumstances in which they occurred (frequency, home, outdoors, going to void, during urinary urgency, nocturia). Severity of LUTSs were assessed by the Urinary Symptoms Profile (USP) Score and patient were classified as with or without urinary incontinence. Number of micturition by night were specifically asked. To take into account motor difficulties and fear of falling, other clinical evaluations were done. The impact of MS on walking was assessed by the 12-Item Multiple Sclerosis Walking Scale (MSWS12) questionnaire, the Expanded Disability Status Scale score, and by clinical test with the Time to be Ready to Void (TRV). Fear of falling was assessed by a simple question and with Falls Efficacy Scale-International (FES-I) Questionnaire.

The primary aim was to assess the relationship between severity of LUTSs and occurrence of falls during the past 3 months. The primary outcome was the importance of overactive bladder (OAB) symptoms with OAB USP score. The secondary outcomes were the existence of urinary incontinence, the warning time (defined as the time from the first sensation of urgency to voiding or incontinence), the importance of nocturia and the other scores of USP questionnaire (low stream and stress urinary incontinence).

The secondary aims were to look for the relationship between severity of LUTSs and occurrence of falls during the past year, and to assess the relationship between falls and the classical risk factors of falls.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Multiple sclerosis (MS) diagnosis
* Lower urinary tract symptoms with or without treatment,
* Expanded Disability Status Scale score between 1 and 6.5

Exclusion Criteria:

* relapse of MS in the past month
* urinary tract infection the day of inclusion
* impossibility to complete the symptoms' questionnaires
The Effect of Both Ultrasound and Fluoroscopy Guide Erector Spinae Plane Blocks

Since the original publication on the erector spinae plane (ESP) block in 2016, the technique of the ESP block has evolved significantly in the last few years. Current reports suggest that the ESP block provides adequate analgesia in thoracic and abdominal sites in a post-surgical and chronic pain patient. However, there were still inconsistencies and unclear spread of local anesthetics in ultrasound guide ESP block.

This study focusing on the spread of local anesthetic in ESP block under ultrasound and fluoroscopy and possible mechanisms of action.

The erector spinae plane (ESP) block was first described by Forero et al. Considering the spread of local anesthetic in the ESP block, it can block more extensive spinal nerves. Therefore, since the first publication, the ESP block has been reported as an effective analgesic for several types of pain and has been used mainly in thoracic surgery. It also used in abdominal surgery, nephrectomy, hernia surgery, and hip surgery, among others. Additionally, the ESP block used not only acute pain management but also chronic pain management.

The spread of local anesthetic in the ESP block investigated in several ways, such as computed tomography (CT) imaging of cadavers, fluoroscopy, chest radiography, and patients' CT imaging. These investigations show that local anesthetics in the ESP block spread to the upper and lower sides of the interfascial plane between the erector spine muscle and the underlying transverse process. Additionally, the local anesthetic spreads beyond the transverse process to reach the costotransverse junctions, after which it permeates the paravertebral space.

Despite the many publications on ESP blocks, there are still inconsistencies and unclear aspects of the technique, such as the spread of local anesthetic and action mechanisms This study focuses on the spread of local anesthetic in ESP block under ultrasound and fluoroscopy and possible mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

1. Thirty-five patients in each group of breast tumor surgery and pain intervention procedure patients.
2. Age \> 20

Exclusion Criteria:

1. Unable to complete questionnaires.
2. With coagulopathy
3. History of thoracic spine trauma or surgery.
4. Allergy to contrast local anesthetics and medium (Iohexol)
Peer Support for Weight Loss Maintenance

The primary aim of this study is to test the efficacy of patient-provided treatment for weight-loss maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-75
* Body Mass Index between 25-50
* English Speaking

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 1 year
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Have no Internet access.
Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.

OBJECTIVES:

Primary

* Determine the complete pathological and clinical response rate in women undergoing surgery for resectable stage I-III breast cancer treated with neoadjuvant dose-intensified epirubicin hydrochloride.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletion for disease progression and pathological and clinical complete response in patients treated with this regimen.
* Correlate gene expression profiles with pathologic complete response, clinical complete response, less than complete response, and disease progression in patients treated with this regimen.

OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks later, patients undergo partial mastectomy or simple mastectomy plus an axillary staging procedure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer

  * Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)

    * Resectable disease
* Unidimensionally measurable disease

  * Primary tumor ≥ 2 cm
* No known distant metastases
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Sex

* Female

Menopausal status

* Not specified

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* WBC ≥ 3,500/mm\^3
* Hemoglobin ≥ 8 g/dL
* Platelet count ≥ 100,000/mm\^3
* No known untreated bleeding diathesis

Hepatic

* AST ≤ 2 times upper limits of normal
* Bilirubin ≤ 1.5 mg/dL

Renal

* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 60 mL/min

Cardiovascular

* LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization

Other

* Not pregnant or breastfeeding
* Fertile patients must use effective contraception
* Negative pregnancy test
* No concurrent illness that would preclude study treatment
* No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim (G-CSF), or any other component of these products

PRIOR CONCURRENT THERAPY: Not specified
Models for Improving Operating Room Productivity: Delays, Cancellations and Pre-admission Testing

The goal of the study is to identify factors that enhance productivity and increase value delivered by hospitals drawing on concepts used in industry for quality and productivity in production and operations management literature. The investigators intend to look at surgeon experience, patient characteristics and pre-admission testing on operating room productivity.


Eligibility Criteria:
Inclusion Criteria:

* All scheduled surgical patients' information gathered in Surgery database from January 2010 thru August 2020 will be included.

Exclusion Criteria:

* Any case type where less than 5 surgeries were performed by a surgeon would be excluded and if the surgeon in question had less than 3 months of data available.
Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy

Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.

Proliferative diabetic retinopathy (PDR) is a well-known complication for both type 1 and type 2 diabetes mellitus (DM) and it is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR, established more than four decades ago by the Diabetic Retinopathy Study (DRS), is panretinal photocoagulation (PRP). The treatment goal is to halt the progression of PDR by destroying parts of the peripheral retina in a pattern fashion and hence preserving the visually important central macular region. The tissue destruction reduces the area of ischemia and reduces the production of vascular endothelial growth factor (VEGF), which drives the formation of neovascular proliferations. In the management of PDR, panretinal photocoagulation (PRP) stands as a cornerstone treatment. In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The choice between these approaches often depends on the practitioner's preference, patient characteristics, and specific clinical circumstances.

Although both single-session and multiple-session PRP are employed in practice, there's an ongoing debate regarding their comparative safety and effectiveness. Older studies suggest a heightened risk of diabetic macular edema (DME) with single-session PRP, while newer research, particularly those involving milder laser techniques, indicates that the risk might be similar regardless of the number of sessions. This inconsistency in findings underscores the need for further research and the investigators aim to shed light over this with this prospective, controlled and randomized interventional study.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
* Visual acuity ≥ 0.1 Snellen.
* CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
* Clear media and adequately dilated pupil for PRP.

Exclusion Criteria:

* Intraocular surgery within the last 4 months or planned within the next 3 months.
* Previous or current center-involved diabetic macular edema (Ci-DME).
* Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
* Treatment with medications known to risk macular edema.
* Media opacity preventing adequate PRP.
* General medical condition making office laser treatment very difficult or impossible.
Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation

The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.

The aim is to follow the patients after extubation for the lung description.

EIT exam is performed before extubation, during follow-up visits and 48H after extubation

Eligibility Criteria:
Inclusion Criteria:

1. Age\> 65 years
2. Invasive mechanical ventilation time greater than 48 hours
3. known or suspected Chronic obstructive pulmonary disease
4. Known or suspected heart failure
5. Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
6. Patient or trusted person who has been informed of the study and has consented to participate

Exclusion Criteria:

1. Pregnant women, minor patients
2. Patients under extracorporeal circulatory assistance (ECMO)
3. Refusal of the patient
4. Contraindications to the realization of the phrenic nerve stimulation technique:

   * Pacemaker, implantable cardiac defibrillator and other pacemakers
   * Spinal implants, thoracic drains ...
   * Copper allergy
   * Epileptic patients
5. Patients performing uncontrolled body movements
6. Contraindications to the realization of the technique of Electrical Imaging Tomography:

   * Breast circumference not between 70 cm and 150 cm.
   * Body mass index (BMI) greater than 50
   * Impossibility of placing the CT belt at the level of the chest skin (lesions, bandages, dressings, chest drains ...)
   * Patients with unstable spinal lesions or fractures
   * Allergy to tomography belt materials: silicone, brass, stainless steel
   * Pacemaker, implantable cardiac defibrillator and other pacemakers
7. Patients under legal protection (tutorship / guardianship)
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET

The novel Amplatzer steerable delivery sheath (Abbott Vascular) is found to be safe and effective in performing LAAO procedure. However, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. In this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure Amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.

Atrial fibrillation (AF) is the most common abnormal heart rhythm associated with substantial morbidity and mortality. It is one of the strongest risk factors of systemic thromboembolism (TE), with stroke being the most serious outcome. Prevention of stroke is the cornerstone of managing AF, which can be achieved either by oral anticoagulation (OAC) or Percutaneous left atrial appendage occlusion (LAAO) in patients who have a contraindication to OAC. Heterogeneity in cardiac chamber size, interatrial septum, LAA anatomy and orientation, operator experience and currently available fixed curve sheaths add to the complexity of the procedure. Alignment of LAAO device along the access of the left atrial appendage body is an important factor in improving closure rates. The devices which are currently approved by FDA for LAA closure in the U.S. are Amplatzer Amulet device (Abbott Medical) and Watchman and Watchman FLX devices (Boston Scientific). In a recent study, Amplatzer Amulet device was found to be noninferior in terms of safety and effectiveness, with superior LAA occlusion rates but higher device-related complications as compared to first generation watchman device. The LAAO device sheaths that are used currently have fixed shapes and angles that may not be optimal for some LAA anatomy, which can lead to excessive device manipulation, prolonged procedure time, and potentially suboptimal co-axiality during the process. This may lead to increase device related complications. The new Amplatzer steerable delivery sheath (Abbott Vascular) is designed to provide distal bidirectional steerability of the sheath for Amulet implantation. Such steerability may enable successful endovascular closure of greater proportion of LAA, allow precise position of the transseptal puncture, and potentially reduce procedural times and complications with complex cases.

Investigators hypothesize that the use of novel steerable sheath for LAAO closure is safer and more effective as compared to non-steerable fixed curve sheath

Eligibility Criteria:
Inclusion Criteria:

Patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of Amplatzer™ Amulet™ Left Atrial Appendage Occluder device

Exclusion Criteria:

* Patient been/being implanted with device other than Amplatzer™ Amulet™ Left Atrial Appendage Occluder
* Pregnant or breastfeeding patients
* Prisoners
* Patients not willing to participate in the study
Studying Biomarkers in Urine Samples From Younger Patients With Wilms Tumor

This research study is looking at biomarkers in urine samples from patients with Wilms tumor. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment

PRIMARY OBJECTIVES:

I. To characterize the urinary metabolite signature of 10 stage III, favorable-histology, Wilms tumor patients from the Cooperative Human Tissue Network (CHTN) Databank, as distinct from 10 normal controls.

II. To characterize and compare the urinary metabolite profile in 50 randomly selected, stage III, favorable-histology, Wilms tumor patients enriched with an additional 30 stage III Wilms tumor patients who have relapsed.

III. To establish if the potential poor outcome (defined as relapse) in the favorable-histology group has a specific metabolite signature.

IV. To characterize the urinary metabolite signature of Wilms tumor in patients with unfavorable histology (diffuse anaplasia) and compare it to those with favorable histology.

OUTLINE:

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance (NMR) spectroscopy and principal component analysis (PCA). Tumor tissue may also be examined by NMR and PCA.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stage III, favorable-histology Wilms tumors and patients diagnosed with stage III, favorable-histology Wilms tumors who have relapsed

  * Tumor samples available from both groups
* Urine samples from the CHTN bank
* Control urine samples
* Urine samples from patients with unfavorable histology
* Not specified
* Not specified
A Study to Explore Hereditary Angioedema (HAE) Symptoms and Treatment Patterns in Korean People

This study intends to gather information on HAE attack symptoms, how often the attacks occur, and the number of times treatment is required to manage the attacks in Korean people over a period of up to 11 months.

The main aims of this study are the following:

* To describe the patterns of HAE attacks, including how often they occur, where they happen in the body, how severe they are, the time between attacks, and any warning signs that appear before an attack.
* To assess how HAE is treated, particularly looking at how on-demand treatments are used during HAE attacks.
* To learn about the people who suffer from HAE attacks (e.g. age, gender, for how long they have been suffering from HAE, and if they use danazol to manage HAE).

In this study, already existing data will be collected and reviewed from a mobile application called "MyHAE Story". The study will only review data collected as part of the clinical routine practice. The study will not impact the standard medical care and treatment of participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are participants in the OnHeart PSP program.
* Participants who have registered in "MyHAE Story" mobile application.

Exclusion Criteria:

- Participants who neither have made input to at least one attack nor have run the app by clicking 'myHAE story' tab within the Kakaotalk chat message at least once after app registration.