cyrilzakka/clinical-trials huggingface dataset:
Preventing Type 2 Diabetes in Black Emergent Adult

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

Aim 1. Use formative research to gather recommendations to Tailor AAT+DPP to Black Emergent Adult (EA) Women (Year 1).

Aim 2. Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED (Year 2).

Aim 3. Conduct a pilot randomized trial to examine the feasibility and acceptability, and preliminary efficacy of the adapted AAT+ DPP intervention (Years 3-4; Analysis Year 5).

Eligibility Criteria:
Inclusion Criteria:

* Black women
* between 18-25 years of age
* BMI ≥ 25 kg/m\^2
* At least one binge eating episode weekly
* Prediabetic
* Have access to a smartphone

Exclusion Criteria:

* Have no internet access
* Currently type 2 diabetic
* Currently pregnant
* Are in substance use treatment
* Have received prior or planned bariatric surgery
Home Assessment and Initiation of Antiretroviral Therapy for HIV in Malawi

Despite increasing availability of antiretroviral therapy (ART) for HIV in high prevalence countries, the majority of people with HIV infection still initiate treatment at an advanced stage of disease. This leads to a high risk of death soon after HIV diagnosis. Prompt HIV diagnosis is, therefore, necessary for both individual and public health benefit and is being strongly promoted as international and national policy in Malawi. However timely HIV diagnosis may not in itself be sufficient to ensure ART initiation: this is reflected by the relatively high proportion of individuals who defer treatment-seeking for months or years following diagnosis of HIV.

Here the researchers investigate the extent to which home assessment and initiation of ART adds to the effectiveness of a home-based HIV testing and counseling strategy, using entry to, adherence with, and retention in HIV care as the outcome of interest.


Eligibility Criteria:
Inclusion Criteria:

* Usual resident of an eligible cluster
* Has had a positive HIV test (regardless of source) and requests facilitated access to HIV care from the resident community counsellor
* Confirmatory HIV test is positive
* No previous ART treatment, or less than one month's treatment in the past (including PMTCT interventions) and not currently receiving HIV care
* No contraindications to receiving ART (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
* No acute danger signs requiring hospital referral
* Aged 18 years or older
* Written or witnessed informed consent to participate in the study

Exclusion Criteria:

* Not a usual resident of an eligible cluster
* No previous HIV test, or HIV infection not confirmed by home-based ART nurse
* Already receiving ART, or has had more than 1 month's treatment in the past
* Known contraindication to firstline ART (known hypersensitivity, renal failure, chronic liver disease)
* Acute danger sign present (as defined by Integrated Management of Adult Illnesses, HIV Department, WHO)
* Age younger than 18 years
* Not willing to accept home-based ART initiation
* Suspected or confirmed TB disease will not be an exclusion criteria, but will be an indication for deferral, until completion of the screening algorithm, with initiation of TB treatment if indicated.
Mirror Medacta Shoulder System Pivotal Trial

The purpose of this study is to demonstrate safety and efficacy of the Mirror Medacta Shoulder System in total shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 yr
* Clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis
* Willingness and ability to comply with study protocol

Exclusion Criteria:

* Medical condition or balance impairment that could lead to falls
* Prior rotator cuff surgery
* Cuff tear arthropathy/insufficient rotator cuff
* Insufficient bone quality which may affect the stability of the implant
* Neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes
* Weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation
* Active metastatic or neoplastic disease at the shoulder joint
* Chemotherapy treatment/radiotherapy within 6 mo before surgery
* \>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery
* Pregnancy or plan to become pregnant during study period
* Inability to understand study or a history of noncompliance with medical advice
* Alcohol or drug abuse
* Current enrollment in any clinical research study that might interfere with this study
* Metal allergies or sensitivity.
* Previous or current infection at or near the site of implantation.
* Current distant or systemic infection
* Patient, whose infomed consent form should be taken in an emergency situation
* ONLY for women of childbearing age: a positive pregnancy test (urine / blood)
The Effect of Video-based Education on Anxiety, Pain and Recovery Quality in Patients Undergoing Laparoscopic Cholecystectomy.

The reasons for anxiety before laparoscopic cholecystectomy include the operation of the surgery process, its therapeutic effect, lack of information about the postoperative period and lack of communication. The increase in the preoperative anxiety level in patients undergoing surgical intervention negatively affects the patients\&#39; sleep, recovery and quality of life, length of hospital stay is prolonged, cost increases in hospitals, and socioeconomic losses occur in individuals and institutions. Therefore, this study will be conducted as a randomized controlled experimental study to determine the effect of video-based training given by an operating room nurse to patients undergoing laparoscopic cholecystectomy on preoperative anxiety, postoperative pain and recovery quality.

Considering possible sample loss, it was decided to include 72 patients, 36 in the intervention group and 36 in the control group. One of the patients included in both the intervention and control groups was excluded from the study because he was converted to open cholecystectomy during surgery and was taken to intensive care postoperatively. The study was completed with a total of 70 patients, 35 in the intervention group and 35 in the control group.

Patient Information Form, Surgical Anxiety Scale, Visual Analogue Scale (VAS) and Recovery Quality Scale-15 will be used to collect data.

A total of 2 patients, 1 patients in the experimental and 1 patients in the control groups, were excluded from the study because they were converted from laparoscopic surgery to open surgery.The study was completed with 70 patients (35 experimental and 35 control) who underwent laparoscopic cholecystectomy and met the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,

  * Knows how to read, write and speak Turkish,
  * Patients who will undergo elective laparoscopic cholecystectomy in the General Surgery Service will be included.

Exclusion Criteria:

* Have cognitive, auditory and psychological problems that may affect communication with researchers,
* Using psychiatric medication,
* Undergoing surgical intervention under emergency conditions,
* Subjected to spinal, epidural or local anesthesia during surge
Cognitive Support Technology for Postsecondary Students With Autism Spectrum Disorder

This study will fill important knowledge gaps in the availability of best practices that use innovative methods to integrate the cognitive and vocational needs of students with Autism Spectrum Disorder (ASD) who will be transitioning from 2- and 4-year postsecondary education to employment. Best practices exist from the assistive technology (AT) field to help people compensate for cognitive impairments, and from the vocational rehabilitation (VR) field to enhance employment outcomes for individuals with disabilities. However, these practices have not been integrated to provide needed supports and services to improve the employment outcomes of students with ASD. The study's goal is to expand the availability of innovative practices by testing the efficacy of a technology-driven, long-term, and resource-rich individualized support program that merges assistive technology for cognition and vocational rehabilitation practices. The end products will include technology application guidelines, training and procedural manuals, and resource information that rehabilitation professionals and students with ADS can utilize to enhance technology and mentoring proficiency, academic success, self-determination, and long-term career success for students with ASD.

The knowledge to be gained from this research will have a beneficial impact on students with ASD, rehabilitation professionals, higher education personnel, case managers, and employers who work with people with ASD. There is strong potential for the students to develop skills that will help them succeed in learning as well as employment settings. The ultimate benefit of research activities for the target population will be seen in the improved capacity for postsecondary students with ADS to utilize state-of-the-art technology to accommodate disability-related limitations, address career readiness, and to prepare for and obtain employment after graduation.

Because the risks to subjects are no greater than those associated with everyday life and because the study staff will refer students who are in psychological distress or medical emergency situations to appropriate resources in the community, the minimal risks of this study justify the considerable benefits that this study will yield. Not only will the study benefit participating students, it stands to make important contributions to the knowledge bases in the fields of assistive technology and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Must be a post-secondary student enrolled in degree programs at two-year and four-year colleges or universities within a 60-mile radius of Kent, Ohio
* Must have a clinical diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

* No other exclusion criteria will be applied
Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
* Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
* An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria:

* Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
* Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
* Subjects with more than 2 facial nodulocystic lesions
Pancreatic Endotherapy for Refractory Chronic Pancreatitis

The purpose of this study is to evaluate whether endoscopic ultrasound (EUS) only versus EUS + endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic endotherapy reduces pain in the treatment of chronic pancreatitis with pancreatic duct obstruction.

This is a single center, pilot, sham-controlled clinical trial of ERCP with pancreatic endotherapy for pain secondary to chronic calcific pancreatitis with main pancreatic duct obstruction. Potential subjects will undergo a comprehensive baseline assessment including Quantitative Sensory Testing, to ensure enrollment criteria are met and baseline covariates are measured. Eligible subjects will complete a 14-day run-in period. If eligibility criteria persist, subjects will be randomized to diagnostic endoscopic ultrasound (EUS) + sham pancreatic endotherapy or diagnostic EUS + ERCP with pancreatic endotherapy as defined in the study protocol. Subjects will be followed by a blinded physician for the next 90 days, at which time the pilot trial outcomes will be measured. Regardless of outcomes, all subjects will be followed longitudinally for 12 months after randomization.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years
* Main pancreatic duct obstruction, defined by the presence of one or both of the following features:
* Main pancreatic duct calcification with upstream main duct dilation ≥6mm.
* Main pancreatic duct stricture, defined by the presence of main pancreatic duct narrowing with upstream main duct dilation ≥6mm.
* Baseline average abdominal pain score ≥4 during the run-in period, based on Ecological Momentary Assessment 11-point Numeric Rating Scale
* Ability to provide written, informed consent

Exclusion Criteria

* Symptoms attributable to a pancreatic pseudocyst or walled off necrosis
* Clinical suspicion of pancreatobiliary malignancy\*
* Low probability of follow-up to complete study objectives
* Pregnancy or incarceration
* Medical comorbidities that contraindicate the performance of ERCP
* Previous pancreatic endotherapy
* Current Opioid Misuse Measure score ≥9
* Does not have access to a mobile phone \* Pancreatobiliary malignancy
EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer

The purpose of this research study is to evaluate the outcomes of two standard of care group exercise regimens to increase muscle mass in women who have been treated with breast cancer.

This protocol seeks to analyze patient outcomes of two standard of care, time-efficient, monitored group exercise regimens of high-load resistance training to improve hypertrophy in women who have been treated for ductal carcinoma in situ or invasive carcinoma of the breast.

As part of the standard exercise program, patients will undergo a fitness evaluation at the AHNCI Exercise Oncology and Resiliency Center before the start of the exercise program. This evaluation will be used to customize the patient exercise program. The exercise program consists of small group training sessions held approximately 3 times per week at the center for 12 weeks (3 months). The fitness evaluation and exercise program are standard of care. Participation in this study will last the duration of the exercise program, about 3 months. All group exercise sessions will be closely monitored by the center staff who are Certified Strength and Conditioning Specialists (CSCS).

Eligibility Criteria:
Inclusion Criteria:

Age 20-89 years

* Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
* Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.

Exclusion Criteria:

* Any current treatment with cytotoxic chemotherapy for breast cancer
* Inability to safely engage in group sessions of resistance training as deemed by study PI
* Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
Pediatric Out-of-hospital Cardiopulmonary Arrest

The objective of this observational and retrospective study is to determine the predictive factors of in-hospital mortality following an out-of-hospital cardiopulmonary arrest (CPA) in the population under 18 years old. Data are collected from telephone calls and medical regulation records processed by the health call center of 2 french departments between January 1, 2019, and March 15, 2022. The medical records of the included patients will also be reread in order to obtain the patient's status at 30 days after the CPA.

Detailed description:

The literature reports numerous works evaluating the epidemiological characteristics of pediatric out-of-hospital cardiorespiratory arrest. An improvement in survival has been reported in the case of resuscitation guided by the operator in medical regulation before the arrival of the emergency services. Indeed, the regulation phase at the 15 center in France is of fundamental importance. Recent evolutions, notably with the creation of specific call-taking professions, show the importance attached to improving practices.

The population concerned is characterized by children under 18 years of age, victims of an extra-hospital cardiorespiratory arrest. It is a retrospective study over three years and three months, multicentric, from the emergency service (SAMU) 57 and 69.

The primary endpoint was the all-cause mortality at thirty days of the admission.

The case report form (CRF) will collect the main aspects of telephone management at the 15 centers, out-of-hospital management by the emergency teams, and the personal characteristics of the emergency physicians and out-of-hospital responders (gender, age, family situation, etc.). The medical management in the emergency department and the first stages of in-hospital management will also be analyzed. The patients included who are still alive will receive a notification of non-objection by mail.


Eligibility Criteria:
Inclusion Criteria:

* child under 17 years old
* and call for cardiac arrest or cardiac arrest detected on call

Exclusion Criteria:

* non-real cardiac arrest
Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL

Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects.

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 15-65
2. Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
3. Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days)
4. ECOG score 0-3
5. Liver function: total bilirubin ≦ 3 times the upper limit of normal; Alanine aminotransferase ≦ 3 times upper limit of normal motion; Aspartate aminotransferase ≦ 3 times upper limit of normal motion; (except considering leukemia infiltration)
6. Renal function: endogenous creatinine clearance ≧30ml/min
7. Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

Exclusion Criteria:

1. Ph+ (BCR-ABL1 positive) ALL and known ABL class Ph-Like ALL
2. T cells ALL
3. Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
4. Acute mixed-cell leukemia
5. Central nervous system leukemia
6. HIV infection
7. HBV-DNA or HCV-RNA positive
8. Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
9. Pregnant or breastfeeding patients
10. The study patient was refused enrollment
Reducing Depression-related Stigma and Increasing-treatment Seeking Among Black Adolescents

The purposes of this study are to:

1. test among adolescent the utility of brief video-based interventions to reduce stigma-related attitudes and increase help-seeking intentions toward depression;
2. examine the role of race (Black vs other) as an independent factor in the primary outcome.

Intervention videos will each be of \~120-second duration and feature an underage female professional (age 16) acting as a simulated patient. All three videos will focus on her as an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness.

Assessments will occur at baseline and post-intervention, and will include:

1. Demographics (baseline only);
2. Primary outcome: Depression-related stigma(Depression Stigma Scale \[DSS\]) summary score.
3. Secondary outcomes: a. DSS individual items; b. Help-seeking (General Help-Seeking Questionnaire \[GHSQ\]) summary score and individual items; and bc Racial attitudes: feelings thermometers.

The investigators intend to randomly assign \~1,000 individuals aged 14-18 as follows:

Subjects oversampled for Black participants (50% Black; 50% other);

Randomized, in equal proportions, and stratified by race, to view one of three \~120-second videos of a girl with:

1. No depression control (Black; BC);
2. Depression (Black, following same script as in our earlier study (Amsalem and Martin, 2021), DB); and
3. Depression adjusted (Black, with script adjusted based on input from focus group of Black girls and women; DBa).

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Living in the US
* Ages 14 - 18

Exclusion Criteria:

* None