cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children

Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills).

SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies.

The aim of the study is to investigate the comparative effectiveness of SSL in its traditional and computerized versions on internalizing symptoms in Spanish children between 8 and 12 years of age.

Children will be selected to receive the SSL program based on results on psychometrically robust measurements and inclusion/exclusion criteria. Selected children will be randomly assigned to the conditions of the two intervention groups (traditional and computerized versions of SSL).

Parents and children from the two groups will complete the same measures at baseline and post-treatment. They will also complete these measures at 6 months follow-up, and 12 months follow-up.

Researchers will compare the results of pre-test to post-test assessments in children participating in the traditional and multimedia versions of SSL on depressive symptoms, anxiety symptoms, interference of anxiety on child's life, self-esteem, social skills, social worries, and cognitive emotional regulation.

The investigators will also assess these variables in the intervention group at 6 months and 12 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 - 12 years old.
* Presence of emotional symptoms, which will be assessed using the SCAS and the MFQ, parent versions. The cut-off point for inclusion in the study is a score equal to or above 25 on the SCAS and/or equal to or above 20 on the MFQ.
* Speaking, reading, writing and understanding Spanish.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
* Being receiving current psychological or pharmacological treatment for anxiety and/or depression.
* Not accepting or revoking informed consent to participate in the study.
Ttt of Adenomyosis

to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms

Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.

Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).

Inclusion criteria:

* Age Group: 30-50 years
* Women with adenomyosis
* With or without small fibroids
* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.

Exclusion criteria:

* Presence of a malignancy or pelvic infection.
* An on-going pregnancy or a desire to conceive in the future.
* Absolute contraindication for angiography (renal impairment).
* Chronic debilitating diseases.

Eligibility Criteria:
Inclusion Criteria:- Age Group: 30-50 years

* Women with adenomyosis
* With or without small fibroids
* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.

Exclusion Criteria:

* - Presence of a malignancy or pelvic infection.
* An on-going pregnancy or a desire to conceive in the future.
* Absolute contraindication for angiography (renal impairment).
* Chronic debilitating diseases.
The Effect of Hyperoxia and Hypoxia on Fluorescence Lifetime Imaging Ophthalmoscopy in Healthy Subjects- a Randomized, Double Blind, Crossover Study

The present study aims to investigate whether FLIO can also detect shorttime changes in retinal metabolism induced by hyperoxia and hypoxia. For this purpose, 48 healthy subjects will be included in the present study and changes in FLIO will be assessed during breathing of 100% oxygen to induce hyperoxia as well as during breathing of 12% oxygen in nitrogen to induce hypoxia. Since stimulation with flickering light also induces a higher metabolic demand in the retina (functional hyperemia), thisprovocation test will also applied during breathing of the different gas mixtures and compared to baseline. To gain information about retinal blood flow, optical coherence tomography angiography (OCT-A) will be performed. The results of the present study can help to gain more insight into the physiology of the retinal metabolism and might give grounds to establish new biomarkers in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years

  * Normal ophthalmic findings
  * Ametropia ≤ 6 diopters
  * Normal findings in the medical history and physical examination including ECG unless the investigator considers an abnormality to be clinically irrelevant
  * Nonsmokers

Exclusion Criteria:

Regular use of medication, abuse of alcoholic beverages or drugs

* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* History or family history of epilepsy
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
Identifying Biomarkers in Alzheimer's Disease

Alzheimer's disease is a severe neurodegenerative disorder of the brain that is characterized by progressive loss of memory and cognitive decline. With the ageing population, AD is a major public health problem affecting nearly 35 million people worldwide with numbers projected to rise to 115.4 million by 2050. AD is the only cause of death among the top ten causes that has no prevention or cure . It is believed that novel treatment of AD needs to start early or even at the prodromal stage in order to be effective. Therefore, there is an urgent need to find accurate methods of early detection before patients with AD develop clinical dementia.

This study aims to identify biomarkers for AD in local Chinese population. this study hypothesizes blood-based proteomics, retinal imaging, ASL-MRP and tau PET can improve the accuracy and staging of AD.

This is a cohort study. It involves baseline and 6 yearly follow ups. At baseline, all participants will go through a list of cognitive assessments, blood taking, Brain MRI scan, Brain PET scan and retinal imaging.

At the first five yearly follow ups, cognitive assessment will be performed. For the sixth yearly follow up, automatic retinal image will be performed in addition to cognitive assessment.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* \[For dementia group, clinical diagnosis of "probable Alzheimer's disease" according to recommendation from the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA)

Exclusion Criteria:

* Clinical diagnosis of non-AD dementia
* contraindication for MRI or PET
The Food Phone Project

The Primary Aim of the project is to modify the RFPM for adolescents and to address the concerns identified by the reviewers of the first grant application. We will then test the RFPM's validity (accuracy) compared to the validity of pen-and-paper food records.

The Primary Aim of the project is to modify the RFPM for adolescents and to address the concerns identified by the reviewers of the first grant application. We will then test the RFPM's validity (accuracy) compared to the validity of pen-and-paper food records. Our experience and the literature indicate that the RFPM is acceptable and feasible in school settings. Following modification of the RFPM and pilot testing with 4 adolescents, we will test the reliability and validity of both the RFPM and food records when used by 60 adolescents (12 to 18 years of age). During one week, participants will use the RFPM and during another week they will use food records (the order will be balanced across participants). The accuracy of each method will be examined by comparing energy and nutrient intake (collectively referred to as food intake or FI) to three gold standards: 1) doubly labeled water or DLW (energy intake only, or EIDLW), 2) a laboratory-based test meal (FILaboratory), and 3) food intake during lunch in a school cafeteria (FISchool). User-satisfaction and participant burden will also be compared between methods, and a cost-effectiveness analysis will determine if and under what conditions one method is more cost-effective than the other.

Eligibility Criteria:
Inclusion Criteria:

* boy or girl of any race
* age 12 to 18 years, inclusive
* willing to use the RFPM for one week and pen-and-paper food records for one week
* willing to complete one laboratory-based food test during week 3
* willing to use the RFPM and food records during the laboratory-based test.

Exclusion Criteria:

-weight unstable (\>1.1 pounds weight change in one week based on regressed daily body weights).
Liquid Biopsy-based Early Detection of Ovarian Cancer: a Proof-of-concept Study ( PROFOUND-OC )

This study is a multi-center, observational study aiming at developing a machine learning-based early detection model using prospectively collected liquid biopsy samples from newly diagnosed ovarian cancer.

Peripheral blood samples from ovarian cancer (OC) patients will be prospectively collected to identify cancer-specific circulating signals by analyzing cell free DNA. Based on the comprehensive molecular profiling, a machine learning-driven noninvasive test will be trained and validated through a two-stage approach in clinically annotated individuals. Approximately 168 stage I-II OC patients will be enrolled in this study. Age-matched female controls included in model development were recruited in another study, which are volunteers without a cancer diagnosis after routine medical screening.

Eligibility Criteria:
Inclusion Criteria:

* 40-75 years old
* Clinically and/or pathologically diagnosed ovarian cancer
* No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.
* Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria:

* Pregnancy or lactating women
* Known prior or current diagnosis of other types of malignancies comorbidities
* Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.0 °C) within 14 days prior to blood draw
* Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 30 days prior to study blood draw
* Recipients of therapy in past 14 days prior to blood draw, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamine, hydrazine, arsenic trioxide
* Other conditions that the investigators considered are not suitable for the enrollment
Implementation Strategies for Monitoring Adherence in Real Time

The objective of this project is to identify effective strategies to help patients with lung cancer manage side effects and achieve optimal adherence to oral targeted therapies. To achieve this objective, we will evaluate the effect of a novel, bidirectional conversational agent, compared to usual care, on adherence to oral targeted therapies using a two-arm randomized controlled trial, and explore how multilevel factors impact the acceptability and effectiveness of this strategy by collecting qualitative and quantitative data from clinicians and patients.

Drawing from insights in behavioral economics and implementation science, the goal of our project is to identify effective strategies for improving lung cancer outcomes by helping patients to better manage symptoms and adhere to oral therapies. Given the rapid increase in FDA-approved targeted therapies, the need for such strategies will continue to grow. Our central hypothesis is that conversational agent will improve adherence to oral therapies by targeting patient-level determinants of behavior change. The specific aims are to: 1) Test the effects of a patient-directed intervention (conversational agent) to improve adherence to oral targeted therapies in patients with non-small cell lung cancer.; and 2) Use mixed-methods approaches with clinicians and patients to explore multilevel factors shaping the acceptability, effectiveness, and future implementation of intervention into routine cancer care. Primary trial outcomes (adherence and persistence) will be measured using microelectronic monitoring system (MEMS) caps. Secondary outcomes will be assessed using longitudinal surveys and medical record data.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age \> 18 years) with NSCLC at UPHS who is receiving one of the following nine oral therapies: afatinib, erlotinib, dacomitinib, gefitinib, osimertinib, alectinib, brigatinib, crizotinib, or lorlatinib.
* Patient possession of a mobile device that can send/receive SMS texts
* Ability to respond to questions and engage with "Penny" in English
* Ability to provide informed consent to participate in the study
* Approval from the patient's medical oncologist to be approached

Exclusion Criteria:

* Inability to respond to questions and engage with "Penny" in English
* Inability or unwillingness to provide informed consent to participate in the study
* Inability to engage with SMS text-messaging platform
* Concurrent enrollment in a therapeutic clinical trial
* Taking more than one oral targeted therapy or concurrent chemotherapy during the study window
* Lack of approval from the patient's oncologist
Cladribine, Cytarabine and Idarubicin in Patients With Relapsed Acute Myelocytic Leukemia (AML)

The purpose of this study is to evaluate the safety and the efficacy of cladribine, high-dose cytarabine and idarubicin in the treatment of patients with relapsed acute myeloid leukemia.

Considerable progress has been made in the induction therapy of acute myeloid leukemia (AML); however, current therapeutic results are still unsatisfactory in those with relapsed disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.

The current multicenter phase II study was initiated to evaluate the efficacy and toxicity of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly patients will be treated with a less dose-intensive regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed AML with a remission duration of at least 6 months after first complete remission (CR) or of at least 3 months after second (or higher) CR
* Age \>= 18 years
* Life expectancy of at least three months (without consideration of AML and complications)
* Eastern Cooperative Oncology Group (ECOG) 0-2 (without consideration of AML and complications)
* Written informed consent

Exclusion Criteria:

* Prior therapy of AML with cladribine
* Severe, uncontrolled infection at time of inclusion (enrollment is possible after control of infection)
* Cardiac insufficiency grade III or IV New York Heart Association (NYHA)
* Severe renal insufficiency with a clearance of \< 30 ml/min (if not due to AML)
* Severe hepatic insufficiency with bilirubin \> 3 mg/dl or AST \> 200 U/l (if not due to AML)
* Other severe organ impairment grade III or IV World Health Organization (WHO) (if not due to AML or, in the opinion of the investigator, may not interfere with the procedures in the study)
* HIV infection
* Intolerance to study drugs
* Pregnant or breast-feeding women
* Any other malignant disease which will probably affect the course of AML
Modified Anterior Palatoplasty In Obstructive Sleep Apnea Syndrome

The aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (OSAS).

A prospective analytic study will be conducted on a total number of 20 patients presented with mild to moderate obstructive sleep apnea for whom Barbed suture modified anterior palatoplasty will be performed.

Surgical Steps

* Procedure will be performed under general anesthesia
* Bilateral tonsillectomy will be performed.
* Then, the inferior portion between upper 2/3 and inferior 1/3 of palatopharyngeus muscle will be partially released
* Then, a rectangular shaped strip of mucosa and the underlying submucosa will be removed at the center of the soft palate consisting of 0.5-0.7 mm in length and with width corresponding to the tonsillar fossae distance.
* Then,the stripped area will be sutured by single resorbable polydioxanone barbed bidirectional size 0 monofilament suture by introducing one needle at the center point of the wound then will be passed laterally within the palate, turning around pterygomandibular raphe till it comes out at the most superior part of the raphe at one side the thread will be pulled until it hangs at the central transition zone which is a free zone present between the two directions of the thread.
* Then, again the needle will be passed back through the tonsillectomy bed and then this suture will be suspended around the raphe again; a gentle traction is then applied on the thread only and no knots are taken.T
* The opposite side will be done by the same way.
* Finally, each thread will be come out at the raphe of the same side, for locking of the stitches and looseness prevention; a superficial stitch in the opposite direction is taken, and then the thread is cut while bushing the tissue downward for more traction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate obstructive sleep apnea syndrome.
* Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses
* Patients who are noncompliant with Continuous positive airway pressure (CPAP).

Exclusion Criteria:

* Patients diagnosed with sever OSAS (AHI more than 30)
* The main site of obstruction at retrolingual level or multilevel obstruction.
* Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency).
* Patients with significant craniofacial anomalies affecting airway.
* Patients with BMI\>40 kg/m2.
* Patients unfit for general anesthesia.
* History of previous velopharyngeal or lingual surgeries.
Home Safety Intervention Using a Safe Home Model

This project seeks to determine the efficacy of safety education using a safe home model. The 4 X 8 ft. model is designed to look like a house; each of 4 "rooms" has a focused safety message. Families will be enrolled in the clinic and randomized to one of two groups, the safe home model group and the printed safety education materials (TIPP materials) group. The investigators will compare the retention of safety information among caregivers instructed using these two methods. The hypothesis is that families in the safe home model group will have improved retention of safety information.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of children younger than 6 years old

Exclusion Criteria:

* Language other than English or Spanish
Tongue Fur and Metabolites in Diabetes Mellitus

This study is a prospective cross-sectional study. The investigators enroll participants form the department of endocrinology and of metabolism, China Medical University Hospital. In total, 300 participants , composed of 100 of type 2 diabetes , 100 of pre-DM and 100 healthy participants. The investigators apply tongue diagnosis system, pulse wave analysis, body constitution questionnaires, and nailfold capillaroscopy to assess the differences of TCM diagnosis. After collecting the tongue coating and analyzing the metabolite signals with a flying mass spectrometer, The investigators collect the data to establish metabolite pattern and biomarkers.

This study aims to identify the clinical symptoms of DM with TCM diagnostic tools and investigate the pattern difference and treatment for DM. Furtherly, the investigators add mass spectrometer to analyze the metabolites of tongue coating, the investigators propose to establish a metabolite pattern and biomarker to identify important biological indicators of DM.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 2 DM
2. Clinical diagnosis of pre-DM
3. Participants in the control group had a normal fasting glucose level

Exclusion Criteria:

1. comorbidity of inadequate heart, liver, kidney, or other serious diseases.
2. pregnancy or lactation.
3. history of mental illness.
Lorlatinib Renal Impairment Study

This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment.

This is a Phase 1, open-label, multi-center, single treatment study in subjects with normal renal function and varying degrees of renal impairment. Each subject will receive a single oral dose of lorlatinib administered in the fasted state. Subjects with mild, moderate, and severe renal impairment will be enrolled and normal healthy subjects will be enrolled as matched controls.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects of non-childbearing potential
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Demonstrate stable renal function

Exclusion Criteria:

* Renal allograft recipients
* Any condition possibly affecting drug absorption (eg, gastrectomy)
* A positive urine drug test
* History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) within 6 months before screening.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
* Screening supine triplicate 12 lead ECG demonstrating a corrected QT (QTc) interval \>450 msec or a QRS interval \>120 msec
* Second-degree or third-degree AV block (unless paced) or baseline PR interval \>180 msec at any time prior to dosing of study treatment.
* Abnormalities in clinical laboratory tests at screening
* Pregnant or breastfeeding female subjects
* History of HIV, Hepatitis B, Hepatitis C, HIT, sensitivity to heparin
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation