cyrilzakka/clinical-trials huggingface dataset:
Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)

Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.

The aim of this clinical trial is to conduct an evaluation of whether children who participate in the Kids' Empowerment Program (KEP) have fewer symptoms of depression and anxiety after 12 weeks relative to those in the comparison group.

Further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. The experimental condition consists of both those who experience the KEP in-person in their classroom (n = 60) and 60 in the comparison condition. Standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. Those in the comparison group receive the KEP program in their classroom after the second interview. Children are interviewed at school and parents complete an online survey.

Eligibility Criteria:
Inclusion Criteria:

* Child age 6 to 12 years
* Parent consents to participate interviews and the program
* Parent agrees to two assessments

Exclusion Criteria:

* Child age younger than 6 and older than 12
* Child with significant developmental or cognitive delays prohibiting program participation
Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)

This study will assess the efficacy and safety of initial treatment with sitagliptin and metformin in patients with type 2 diabetes mellitus in China. The primary hypothesis is that after 24 weeks, initial co-administration treatment with sitagliptin and metformin provided greater reduction in hemoglobin A1C (A1C) compared to initial treatment with sitagliptin alone and with metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* has type 2 diabetes mellitus
* is male, a female who cannot have children, or a female who agrees to use birth control during the study
* is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

* Patient has type 1 diabetes mellitus or ketoacidosis
* Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
* Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
* Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* Patient is HIV positive
* Patient is pregnant
Palliative Short Course Radiotherapy for Advanced Thoracic Cancer

The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation therapy in patients with symptomatic advanced thoracic cancer.

The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of advanced thoracic cancer.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven advanced thoracic cancer
* excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) \<3

Exclusion Criteria:

- prior radiotherapy to the same region
Biomagnetic Characterization of Gastric Dysrhythmias:Study 2

The purpose of this study is to use the Squid magnetometer (Superconducting QUantum Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach and intestines.

The Squid magnetometer is a non-invasive investigational device that measures the electrical activity in the smooth muscle of the intestines. Volunteers with normal bowel activity, those with gastric problems, and diabetics with gastric problems will be studied under the SQuid to determine normal and abnormal activity. Diabetics with an abnormal gastric emptying study will be asked to participate.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers, those with stomach problems, and Diabetics with abnormal gastric emptying study

Exclusion Criteria:

* Diabetics with a normal gastric emptying study
* Participants with claustrophobia
Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair

The aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia.

Epigastric hernias are usually occult in obese patients, and their symptoms may mimic peptic ulcer or gallbladder disease . Hernia repair is associated with considerable postoperative pain.

The recto-intercostal fascial plane block (RIFPB) is a new novel approach that was developed by Tulgar et al., 2023 who hypothesized that when we inject a local anesthetic into the interfacial plane just inferolateral to the xiphoid, between the rectus abdominis muscle and the 6-7th costal cartilages (hence, between the cartilages and the intercostal muscles between them), blockade of the anterior branches of the nerves passing through this area can be guaranteed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for elective epigastric hernia repair.

Exclusion Criteria:

* Obese patients with body mass index (BMI) \>35 kg/m2.
* Patients with a large hernia containing bowel.
* Patients with local anesthetic allergy.
The MATRIX OCT Substudy

Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.

This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.

A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:

* patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
* patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
* patients whose anatomy is suitable for OCT evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:

  1. patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
  2. patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
  3. patients with a coronary anatomy suitable for OCT evaluation.

Exclusion Criteria:

* The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.
Health-related Quality of Life and Late Effects Among SURVivors of Cancer in Adolescence and Young Adulthood: The SURVAYA Study

Rationale: Adolescent and young adult (AYA) cancer survivors, diagnosed between 18-39 years, much more than children, suffer from delay in diagnosis, lack of centralization of care, age-adjusted expertise and follow-up care. The distribution of tumor types, biology, risk factors, developmental challenges and treatment regimens are different in AYAs compared to children. Therefore findings derived from childhood cancer survivors cannot be extrapolated to AYAs. Likewise, several large tumor-specific cohort studies exist that do not specifically address unique AYA age-specific issues. Globally, so far, the identification of AYA patient subgroups that might be more susceptible to poor health outcomes has not been systematically addressed. The role of sociodemographic and treatment-associated risks, external exposures (e.g. lifestyle) and host factors (e.g. genetic); or combinations of influences for impaired (age-specific) health outcomes, remains largely unknown. Understanding who is at risk and why, will support the development of evidence-based AYA prevention, treatment and supportive care programs and guidelines.

Objective: To examine the prevalence, risk factors and mechanisms of impaired health outcomes (health-related quality of life and late effects) among a population-based sample of AYA cancer survivors. Study design: Retrospective, population-based, observational cohort study.

Study population: AYA cancer survivors, diagnosed at age 18-39 years between 1999-2015, identified from the Netherlands Cancer Registry (NCR), and alive 5-20 year after diagnosis Main study parameters/endpoints: Health-related quality of life; late effects


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed cancer diagnosis;
* Age 18 - 39 years at time of first cancer diagnosis;
* Provide written informed consent.
* Treated in an Academic hospital or Netherlands Cancer Institute
Safety & Efficacy Study of HTU-520 in the Treatment of Distal Subungual Onychomycosis of the Toenail

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of HTU-520 in subjects with clinically diagnosed onychomycosis of the great toenail.

A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety \& Efficacy of HTU-520 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of DSO for at least one great toenail
2. Direct microscopy of subungual debris positive for hyphal elements (KOH test)
3. Culture confirmation of the growth of a dermatophyte
4. Good general health
5. Willing to refrain from using any lotions, creams, liquids, or polish on treated toenails
6. Willing to refrain from receiving pedicures for the duration of the study
7. If female, using an acceptable form of birth control

Exclusion Criteria:

1. Unable to apply test product onto toenails by him/herself
2. Use of topical antifungal agents on the nail within 1 month
3. Uncontrolled diabetes
4. Onychomycosis of the fingernails
5. Confirmed non-dermatophyte infection of the target toenail
6. Structural deformities of the target toenail, open wounds, lesions, sores, surgery on the feet or toenails
7. History of severe or chronic immunosuppression, an immunocompromised condition
8. Any systemic or dermatologic disorder, such as severe eczema, or severe atopic dermatitis
9. Psoriasis of the toenails
10. Hypersensitivity or allergy to topical preparations (including terbinafine) or adhesive dressings
The Wise App Trial for Improving Health Outcomes in PLWH

The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.

Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HIV
* Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
* Be able to communicate and read in English or Spanish
* Live in the US
* Have a smartphone
* Be taking ART medications

Exclusion Criteria:

* Participation in any other mobile app study for PLWH, including text messaging studies
* Diagnosis of a clinical problem that would preclude someone from using a smartphone
Contingency Management for Smoking in Substance Abusers

Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.


Eligibility Criteria:
Inclusion Criteria:

* current alcohol, cocaine, marijuana, or opiate abuse or dependence
* smoke ≥ 10 cigarettes per day
* expired CO \> 8 ppm
* self-reported interest in quitting smoking,
* ≥ 18 years old
* willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,
* English speaking

Exclusion Criteria:

* currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
* cognitive impairment
* in recovery for pathological gambling
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes

This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on the lowest starting dose of 3 mg and gradually increased until they reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final three doses will be randomized (i.e., decided by chance). Participants will be administered one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period. Women who can get pregnant will be checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg) are approved for the treatment of type 2 diabetes in the US, in the EU and in some other countries, under the brand name Rybelsus®.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
* HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
* BMI equal to or above 25 kg/m\^2
* Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
* No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*:

  * Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
  * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
  * Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
* Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
* Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).

Exclusion Criteria:

* Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
FUS-TB VS COG-TB in Small Lesions of Prostate Cancer

To compare the positive detection rates of COG-TB vs FUS-TB for prostate cancer with PI-RADS 4 small lesions.

Prostate cancer (PCA) is the most frequent malignancy in male urogenital system. According to the World Health Organization's 2020 GLOBOCAN statistics, there are approximately 1.4 million new cases and 375,000 deaths worldwide. PCa is the second most common tumor in male patients after lung cancer and ranks fifth among cancer causes of death.

Currently, prostate specific antigen ( PSA ), digital rectal examination (DRE), multi-parametric magnetic resonance imaging (mpMRI), prostate specific membrane antigen positron emission Tomography/computed tomography (PSMA PET/CT) and other detection methods have played an important role in the diagnosis of PCa, but the gold standard for confirming PCa is the histopathological examination of prostate biopsy. Performing mpMRI before biopsy can help detect and locate prostate cancer with ISUP grade ≥2. Studies have shown that the prostate imaging reporting and data system (PI-RADS) may help improve the detection of clinically significant cancers. Biopsy should be considered when PI-RADS score 4 or 5.

This clinical study intends to use the mpMRI-TRUS image fusion ultrasound system to assist in guiding FUS-TB, comparing to COG-TB to evaluate the application value of mpMR-TRUS image fusion in the detection of PCa in prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* 1) male who are between 18 to 80 years old; 2) meet any of the following criteria:

  1. suspicious nodules of prostate under digital rectal examination(DRE), with any PSA value;
  2. PSA≥10μg/L;
  3. 4μg/L≤PSA\<10μg/L,f/t PSA≤0.16; 3) suspicious lesions under mpMRI, at least one lesion \<5mm, PI-RADS 4; 4) good compliance; 5) must sign the informed consent form.

Exclusion Criteria:

* 1) diagnosed prostate cancer or acute prostatitis; 2) acute infection, or clinically significant urinary tract infection; 3) performed prostate puncture within 1 month; 4) cardiac insufficiency; 5) having high risk of bleeding or taking anticoagulants for a long time; 6) severe internal or external hemorrhoids, perianal or rectal lesions; 7) having severe osteoarticular diseases that can not be performed lithotomy; 8) hypertensive crisis; 9) patients who should not be anesthetized; 10) patients with mental illness or mental disorders and unable to understand the informed consent; 11) patients with electronic devices such as built-in artificial pacemaker, cochlear implants or nerve stimulators; 12) other surgical contraindications, or those considered unsuitable by the investigators.
Measuring Adherence to Medication for Depression and Attention-deficit Hyperactivity Disorder

Poor adherence is a common reason for treatment failure in many fields of medicine, and likely affects common psychiatric treatments as well. Members of the present study team have used Medication Event Monitoring System (MEMS®) caps effectively to objectively monitor adherence in skin disease, and have shown that they provide a much more accurate measure of adherence behavior than self-reports, pill counts, or serum drug concentrations. The present study will use MEMS® caps to measure adherence in 10 patients with depression and 10 patients with attention-deficit hyperactivity disorder (ADHD) from a student clinic population. The aims will be to show the usefulness of MEMS® caps in measuring adherence to psychiatric treatment, and gather data on typical adherence rates for depression and ADHD patients on typical treatment regimens. The data obtained will be used to inform future studies that use an intervention to improve adherence behavior and ultimately disease outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Any male or female, at least 18 years of age, using the Student Health Clinic, with a diagnosis of depression or ADHD.
* Written consent of participation must be given by the subject.

Exclusion Criteria:

* Subject is less than 18 years of age.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication while participating in the study. (Patients who are on a stable dose of non-study-related prescription medications for at least 4 weeks prior to the study, and throughout the study period, are not excluded.)
* Female patients whose medications may be harmful during pregnancy must be on an acceptable form of birth control, otherwise they will not be eligible for participation.