cyrilzakka/clinical-trials huggingface dataset:
Childhood Chronic Illness: An Educational Program for Parents of Children With On-Going Health Care Needs

The long-term goal of this research is to strengthen parents' abilities to manage the complexities of childhood chronic illness. To achieve this goal, the team of parents, health care professionals, and researchers proposes the following specific aim:

* Develop, implement, and test a unique psycho-educational program, Living with Childhood Chronic Illness (the Program), for effectiveness with parents of children who have chronic illnesses.

The investigators propose the following hypotheses:

At both 6 and 12 month follow-up points, parents taking part in the intervention, in contrast to control parents, will have:

1. Greater perceived self-efficacy regarding their ability to manage the child's chronic condition;
2. Greater parental ability to involve their child in shared management activities;
3. Greater parental ability to cope at 6 and 12 months following the end of the intervention;
4. Greater emotional health; and
5. Greater parental perceived family quality of life.

Parents will enroll in the study by contacting the study number: 206-987-1000 or by sending an email message to family.strengths@seattlechildrens.org. They will complete a survey taking no more than 60 minutes. Parents will then be randomized to either take the class immediately or be in the control group which can take the class in 12 months. At the end of 6 and 12 months all the participants again take the survey.

Classes are 7 weeks in length, 2 hours each and are offered at various locations throughout the Greater Seattle area.

Eligibility Criteria:
Inclusion Criteria:

* Child 2-11 years of age, with diagnosed chronic illness
* Parent at least 18 years of age, able to speak and read English at 4th grade level and able to attend a 7 week two-hour class program

Exclusion Criteria:

* Child in active hospice treatment
Benepali® PEN Patient Satisfaction Survey

The main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a standardised participant questionnaire. In addition, it is to be investigated whether differences exist in general participant satisfaction between participant groups who have undergone various prior treatment and/or have previous experience with application systems (participants new to the use of biologics, participants changing over from a prefilled injection or changing over from another pre-filled pen) and between participants of the various indication groups. Furthermore, the participants are to evaluate various aspects of using the Benepali® pre-filled pen based on their personal experience, such as e.g. handling, user-friendliness and features of the Benepali® pre-filled pen, as well as the effectiveness of the training on injection with the Benepali® pre-filled pen, based on participant satisfaction with the training received with the training pen and the evaluation of the training material received.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of moderate to severe active rheumatoid arthritis, severe active and progressive rheumatoid arthritis, active and progressive psoriatic arthritis, severe active ankylosing spondylitis, or severe non-radiographic axial spondyloarthritis
* Current treatment with the Benepali® pre-filled pen in accordance with prescribing information for at least 3 months beforehand
* The patient has signed a declaration of consent to take part in the study

Key Exclusion Criteria:

* Patients who are receiving Benepali® for the treatment of moderate to severe plaque psoriasis
* Patients who exhibit contraindications in accordance with the prescribing information for Benepali® and therefore treatment with Benepali ® is not indicated

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Development of an Epigenetic Biomarker for Prediction of Fetal Alcohol Spectrum Disorder

The objective of the study is to validate epigenetic changes as biomarkers in a prospective sampling of newborn blood samples collected at birth (umbilical cord blood) and during routine screening (heel stick blood) in newborns concurrently tested for alcohol exposure levels by PEth blood spot testing.

Fetal alcohol spectrum disorders (FASD) are a group of conditions that can occur in a person whose birth mother consumed alcohol during pregnancy. The effects can include physical problems and/or difficulties with behavior and learning. When clinicians identify FASD early, intervention approaches can minimize the potential impact and lessen or even prevent disabilities. Thus, objective markers for prenatal alcohol exposure are desired.

Using dried blood spots from the umbilical cord and a heel stick of newborns, this study will use Phosphatidylethanol (PEth), a novel biomarker for alcohol exposure, to identify and characterize infants' exposure to alcohol before birth. Additionally, the dried blood spots will used to validate the use of screening assays using epigenetic changes as markers for prenatal alcohol exposure. Epigenetic changes are heritable changes in DNA that affect DNA function but do not change DNA sequence. The use of PEth testing will allow for the correlation of prenatal alcohol exposure levels with epigenetic changes. Women will be consented prior to delivery for participation in this prospective study. The study will be conducted in collaboration with United States Drug Testing Laboratories, Inc. (USDTL).

Eligibility Criteria:
Women:

Inclusion criteria

* Women aged ≥ 18 years and currently pregnant at time of enrollment
* Women who plan to and then deliver their infants at CAMC Women and Children's Hospital

Exclusion criteria

* Women aged \< 18 years
* Women not pregnant
* Women who do not plan to deliver or did not end up delivering their infants at CAMC Women and Children's Hospital

Infants:

Inclusion criteria

* Birth mother was consented prior to delivery
* Live birth at CAMC Women and Children's Hospital

Exclusion criteria

* Birth mother was NOT consented prior to delivery
* Stillborn
Effect of Drainage on Laparoscopic Gastric Bypass Surgery

Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. The purpose of this study is to determine the use of drain, which closely affects these criteria; And the effect on patient comfort.

Question the necessity of routine use of drain in RYGB surgeon

Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patients

Exclusion Criteria:

* Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery) were excluded
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY)

The goal of this observational study is to assess the natriuretic effect of intravenous acetazolamide in patients admitted with heart failure and persistent congestion despite treatment with intravenous furosemide and sodium-glucose cotransporter type 2 (iSGLT2) inhibitors.

The main question it aims to answer is whether there is a difference in natriuresis 48 hours after acetazolamide association to medical treatment recommended by the guidelines (furosemide and ISGLT2).


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for acute heart failure and ≥ 1 clinical sign of volume overload (edema, ascites, or pleural effusion).
* NTproBNP levels \>1000 pg/mL or BNP \>250 ng/mL on admission.
* Under treatment with furosemide and iSGLT2 according to European guidelines and indication of association of another diuretic due to residual congestion data defined by ADVOR SCORE\>1.

Exclusion Criteria:

* Systolic blood pressure \<90 mmHg or mean arterial pressure \< 65 mmHg.
* Maintenance treatment with acetazolamide/ Treatment with acetazolamide in the month prior to inclusion in the study.
* Anticipated need for intravenous inotropes, vasopressors or nitroprusside during the study.
* Contraindication to ISGLT2.
* Type 1 diabetes mellitus
* GFR \< 20 ml/min/m2 or renal replacement therapy/ultrafiltration at any time prior to the study.
* Anticipated exposure to nephrotoxic agents, such as iodinated contrast during admission.
* Concurrent diagnosis of acute coronary syndrome.
* History of congenital heart disease requiring surgical correction.
* History of cardiac transplantation and/or ventricular assist device.
* Pregnant or breastfeeding patients.
* Inability to adequately collect diuresis.
* Serum potassium less than 3.5 mEq/L.
* Venous pH \<7.30
* Severe aortic stenosis or obstructive hypertrophic cardiomyopathy.
* Sulfonamide allergy, liver cirrhosis, renal lithiasis.
Photographing the Skin During Photodynamic Therapy

Photodynamic therapy (PDT) is used to treat some types of sun-damaged skin and low-grade forms of growths. A cream is applied to the skin, and the chemical in this cream is absorbed in to the skin and converted in to a 'photosensitiser'. This photosensitiser is fluorescent, meaning that it produces red light when blue light is shone on it. By measuring how much light is given off with a camera, the investigators can determine how much photosensitiser is present in the skin. Also, it is thought that more of the chemical is converted to the active photosensitiser if the skin is warmer, so the investigators plan to measure the temperature of the skin using a thermal camera. Light is shone on to the skin and this activates the photosensitiser, treating the problem area and leaving healthy skin intact. This research will increase the investigators understanding of how PDT works, and may help the investigators to improve treatment regimens so that they can be made more effective and better tolerated


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients presenting with superficial BCC or Bowen's disease (one or two lesions and diagnosed either clinically or histologically and untreated or having had no treatment for 4 months or longer) 2. Adult males and females, \>18 years only 3. Capable of giving informed consent 4. Able to understand and adhere to protocol requirements

Exclusion Criteria:

* 1. Patients skin lesions have had previous treatment in the last 4 months 2. Unable to give informed consent 3. Known allergy to Metvix® 4. Known to have a light sensitive disorder 5. Pregnant, breastfeeding or planning to conceive
S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

Eligibility Criteria:
Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma;
2. ECOG performance status: 0-1;
3. No treatments prior to enrollment;
4. At least one measurable lesion on CT, MRI or esophageal barium exam;
5. Normal functions of heart, lung, liver, kidney and bone marrow;
6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
7. Informed consent signed.

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
The Effect of Continuous Management of Suction Cuff Pressure and Subglottic Irrigation Suction on Preventing VALRI Study

Assessing the effectiveness of continuous cuff pressure management combined with subglottic suction irrigation in reducing ventilator-associated lower respiratory tract infections (VALRTI) in mechanically ventilated patients at high risk of aspiration.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Undergoing endotracheal intubation or tracheostomy;
3. Expected duration of mechanical ventilation exceeding 72 hours;
4. Presence of one or more high-risk factors for reflux/aspiration: recurrent laryngeal nerve injury, cerebral infarction/cerebral hemorrhage (new or pre-existing swallowing dysfunction), cranial surgery/traumatic brain injury (TBI), neuromuscular junction disorders (e.g., myasthenia gravis, muscular dystrophy, Parkinson's disease, or other conditions that weaken swallowing muscle strength and coordination), continuous use of muscle relaxants for ≥ 48 hours during mechanical ventilation, ICU-acquired myopathy, ICU-acquired weakness, gastroparesis (gastric residual volume \> 500 mL/6 hours), or impaired consciousness;
5. Voluntary participation in the study by the subject or their legal representative, with signed informed consent.

Exclusion Criteria:

1. Expected duration of mechanical ventilation less than 48 hours;
2. Pregnant or breastfeeding women;
3. Patients with tracheoesophageal or bronchopleural fistula;
4. Difficult intubation (more than three attempts) or patients with reflux/aspiration during intubation (with lung injury and secondary pulmonary infection);
5. Patients with irreversible disease, end-stage conditions, or those expected to die in the near future;
6. Patients already diagnosed with ventilator-associated pneumonia (VAP), i.e., excluding hospital-acquired pneumonia;
7. Patients participating in other clinical trials that are expected to influence the results of this study;
8. Patients deemed unsuitable for inclusion in the study by the investigator.
mHealth for Smoking Cessation in Public Housing

Smoking rates among public housing residents are more than twice as high as in the general population. In August 2018, the U.S. Department of Housing and Urban Development (HUD) required all public housing in the U.S. to become smoke-free. While HUD recommended that Public Housing Authorities provide smoking cessations services, at present, the D.C. Housing Authority (DCHA) does not offer any cessation services to its residents. Low-income smokers face unique challenges to smoking cessation and require sustained support for smoking cessation. Digital interventions such as text messaging programs and quitline (QL) phone counseling are scalable, evidence-based interventions for smoking cessation that can provide support over an extended timeframe at low cost.

The aim of this proposed research is to conduct a feasibility trial to assess the acceptability, levels of engagement, and preliminary efficacy of an integrated program that combines text-messaging for smoking cessation and text messages providing proactive linkage to the quitline compared to a single passive quitline text message referral among DCHA residents. The investigators hypothesize that the integrated program (combining text messages for smoking cessation and proactive quitline linkage) will yield significantly higher rates of quit attempts than passive quitline referral only.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* resident of D.C. public housing
* smoked a cigarette in the 7 days prior to screening (self-report)
* has daily access to a working cell phone with an unlimited text message plan

Exclusion Criteria:

-
Long-term Follow-up Study of AL-001 Ophthalmic Injection in Subjects with WAMD

This study is designed to evaluate long-term safety and efficacy of AL-001 ophthalmic injection following suprachoroidal space(SCS) administration in subjects with wAMD. Eligible patients, are those who were previously enrolled in a clinical study in which they received a single dose of AL-001 administered via suprachoroidal space injection.


Eligibility Criteria:
Inclusion Criteria:

* The subjects enrolled in AL-001 study and received AL-001 ophthalmic injection.
* The subject or their legal representative agrees to participate in this study and signs a written ICF.
* The subjects are willing and able to follow planned visits and procedures.

Exclusion Criteria:

* None
Alternative Birth Positions During the Second Stage

Simulation training provided before clinical practice at many universities helps students feel confident and well prepared for the clinical environment. Simulation-based learning not only improves professional competence in midwifery educators but also equips and empowers midwifery students in practice. In undergraduate midwifery education, students are provided obstetric skills training on electronic fetal monitoring (EFM), delivery management, shoulder dystocia, postpartum hemorrhage, breech delivery, umbilical cord prolapse and perineal repair (incision and episiotomy). It has been determined that simulation-based training positively affects the perceived readiness of the participants. It is emphasized that health personnel should be encouraged to freely choose birth positions and be informed about the risks and benefits of upright and supine positions. This study will be conducted to evaluate the effect of midwifery students' use of alternative birth positions in the second stage of labor on students' anxiety, self-efficacy, skill and knowledge levels.


Eligibility Criteria:
Inclusion Criteria:

* Continuing their third year in the 2024-2025 Spring semester,
* Students who have passed the normal birth management course

Exclusion Criteria:

* Students who fail the normal birth management course
Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence

Today the standard for the diagnosis and monitoring of bladder tumors is bladder endoscopy. The performance of this exam is not perfect. With this work, based on artificial intelligence, the investigators wish to combine endoscopy with a complementary diagnostic tool in order to improve patient care. The main objective will be to reduce diagnostic errors / wanderings in patients treated or followed for bladder tumors, by imposing a new standard of diagnostic bladder mapping (high PPV and VPN, high precision)(primary purpose diagnostic). The secondary objective will be to homogenize and systematize the descriptive part of the lesions, and to use AI to better characterize tumor aggressiveness. The final objective being to validate a new precision tool (diagnostic companion) essential for developing and standardizing the therapeutic management of bladder tumors (correcting inter-observer heterogeneity).

In this project, video frame will be first extracted from our dataset of cystoscopy videos hosted in in the Next Cloud Recherche. Selected medical image will be segmented and analyzed using our pre-trained CNN model with a feature detection algorithm to obtain features.

Data will be analyzed on both patient and lesion levels. The study will assess the Bladder-PAD accuracy on the detection of bladder tumors, and its ability to predict tumor risk of recurrence and progression.


Eligibility Criteria:
Inclusion Criteria:

* unifocal primary or recurrent suspected bladder cancer with tumor size less or equal than 3 cm
* multifocal primary or recurrent suspected bladder cancer less or equal than 5 lesions and with tumor size less or equal than 3 cm.

Exclusion Criteria:

* Evidence of more than 5 tumors or more than 3 cm
* computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)
* computed tomography/magnetic resonance evidence of distant metastases (lymphatic or organic)
* Exclusion criteria will include gross hematuria and bacillus Calmette-Guerin (BCG) treatment or chemotherapy within 3 months of inclusion
* An exception will be made if patients had received only a single course of chemotherapy immediately following TUR
* Patients objecting to the use of their data in the context of research.
Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome

This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18-75 years of age.
* Male or female patients are eligible.
* Patients with a diagnosis of hypertension:
* Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting systolic blood pressure (MSSBP) \> 150 mmHg and \< 180 mmHg at Visit 1.
* Patients treated with antihypertensive monotherapy must have a MSSBP ≥ 140 mmHg and \<180 mmHg at Visit 1.
* Patients taking amlodipine monotherapy MSSBP \> 140 mmHg and \< 180 mmHg at visit 1.
* All patients must have a MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 3, the end of the amlodipine run-in period.
* Metabolic syndrome.
* Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).

Exclusion Criteria:

* Severe hypertension (office cuff MSDBP ≥ 115 mmHg and/or MSSBP ≥ 180 mmHg).
* History or evidence of a secondary form of hypertension.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
* Serum sodium \< 135 mmol/L at Visit 1 if confirmed on repeat sample.
* Serum potassium \< 3.5 mmol/L or ≥ 5.3 mmol/L at Visit 1, if confirmed on repeat sample.
* Type 1 diabetes mellitus.
* Type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months.
* Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Effect of Antiseizure Medication on Hormone Levels and Sexual Function in Men With Epilepsy

The purpose of this study is to determine if antiseizure drugs affect hormone levels and sexual function in men with seizures.

This study involves donating two small tubes of blood for hormonal testing, which will be drawn at the same time as your routine blood draw for the monitoring of your antiseizure medication. You will also be asked to fill out a short confidential questionnaire regarding your sexual interest and function.

Eligibility Criteria:
Inclusion Criteria:

* Must be a male between 18-50 years of age
* Must have seizures
* Must be on antiseizure medication for at least six months duration

Exclusion Criteria:

* Must not have taken hormones, major tranquilizers or antidepressants for at least 3 months