cyrilzakka/clinical-trials huggingface dataset:
Exergaming Intervention in ALL Patients

This is a pilot feasibility study to collect preliminary data for a large-scale exergaming intervention in children undergoing maintenance therapy for Acute Lymphoblastic Leukemia (ALL). Patients, ages 5-17 years will be randomized to the intervention or non-intervention control group. The intervention will consist of 30 minute sessions of exergaming 3-5 times a week for 6 months, with weekly assessment of exercise level and phone calls by kinesiology graduate students for safety and compliance. Physical activity at baseline and at the end of study will be assessed using accelerometers. Outcome measures will include: anthropometrics, blood pressure, body composition, visceral fat, vascular function, fasting insulin, fasting glucose, LDL-cholesterol, HDL- cholesterol, triglycerides, functional mobility and endurance, and strength.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility will not be restricted by race or sex
* Pediatric patients with ALL diagnosis, treated at the University of Minnesota Amplatz Children's Hospital or Children's Hospitals and Clinics of Minnesota
* At least 3 months into the maintenance phase, with at least 6 months left of maintenance therapy
* Age 5-17 years at time of study enrollment
* Not smoking
* Currently not involved in a regular (3 times per week) exercise program

Exclusion Criteria:

* Individuals with a physical or mental impairment which would preclude their ability to perform the intervention.
* Bone marrow transplant recipients.
* Any woman currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing
* Due to the intervention being in English, non-English speakers will be excluded
Sleep Satisfaction and Psychomotor Performance of Adults

Primary Objective:

To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration

Secondary Objective:

To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration


Eligibility Criteria:
Inclusion criteria:

* Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).
* Accepting to participate in the study and signing informed consent

Exclusion criteria:

* Pregnancy or breastfeeding.
* Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.
* History of substance abuse or dependence (including alcohol) within the past year.
* Hypersensitivity to zolpidem or its excipients.
* Severe hepatic insufficiency
* Severe and/or acute respiratory insufficiency
* Myasthenia gravis.
* OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.
* Severe medical illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Incentivizing Planning & Output in Exercising

This study will test whether incentivizing pre-workout activities (i.e., planning workouts) is more effective than incentivizing actual workouts. This study has two conditions: planning condition (with incentives for planning) vs. output (with incentives for working out). The focus of the incentives will be reinforced by three text messages per week and weekly emails.

Gym members register online to participate in a 28-day workout program. Upon registration, participants are assigned to one of two conditions (a condition that incentivizes planning or a condition that incentivizes workouts). Upon registration, participants are prompted to create a workout schedule and are given tips about how to create a workout habit. Over the 28-day intervention period, participants receive text message reminders prior to their scheduled workouts and emails reminding them of their schedules. In both conditions, participants receive points every day that they go to the gym, which can be redeemed for a gift card after the intervention period. In the planning condition, participants can receive bonus points for responding to each of three text messages each week asking about their plans for going to the gym. In the output condition, participants receive bonus points for their first three workouts each week.

Eligibility Criteria:
Inclusion Criteria:

* Has 24 Hour Fitness gym membership

Exclusion Criteria:

-
Transcranial Magnetic Stimulation for Low Back Pain

The purpose of this study is to test whether non-invasive brain stimulation, such as Transcranial Magnetic Stimulation (TMS) may alleviate pain associated with various chronic pain conditions. We will test various methods of TMS to identify a treatment approach that may reduce the symptoms of chronic pain for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patient with Chronic Low Back Pain
* Meets minimum pain level criteria
* Ability to perform the experimental Task and Procedures

Exclusion Criteria:

* MRI contraindication if an MRI exam is required per protocol
* TMS Contraindication
* History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
* Neurologic illness that would interfere with brain integrity
* Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
* Currently pregnant or planning to become pregnant.
* On going legal action or disability claim.
One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease

Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers.

Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.

The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers.

These drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted.

Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists.

The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Eligibility Criteria:
Inclusion Criteria:

Ischemic heart disease, willing to participate, compliance to medical therapy

Exclusion Criteria:

Patients with acute coronary syndrome; pregnancy
Effect of Azithromycin in Preventing Premature Labour

This is a prospective observational case controlled study. The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.

The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin

A prospective randomized clinical study was conducted in the outpatient clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt, between October 01, 2021, and April 30, 2022. The study included 211 pregnant women aged between 20 to 41 years. These patients were randomized into three groups.

The first group which was the control group, included pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments (progesterone) for prolongation of pregnancy. While the second group which was the first test group, involved pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus azithromycin for 5 days every month.

. The third group was the second test group in which the pregnant women administerated Azithromycin and clindamycin (Dalacin®) vaginal gel 5 times per month.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with \<34 weeks of gestation,
* Hospitalization for risk of preterm labour,
* Threat of preterm labour, or preterm labour itself.
* Threat of preterm labour and preterm labour will have to be diagnosis cited in the medical record by the physician.
* Women at risk of preterm labour must have one of the following conditions cited in their record: sludge, short cervix, cerclage, or bulging membranes

Exclusion Criteria:

* Patients were excluded from the current study in case of the use of antibiotics within 14 days before the admission (except for pericerclage prophylaxis, or streptococcus B prophylaxis), PPROM or fetal extraction required \<37 weeks.
Impacting the Disposal of Unused Opioid

The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject.

Opioids are used to treat acute pain after surgery, but can lead to misuse and abuse. Very few patients properly dispose of unused opioids and the majority of opioids are stored in the home in unlocked containers as opposed to being properly disposed of. Improper disposal of opioid medications is a concern due to the potential for nonmedical use and has the potential to cause injury or death for patients and their family members that can access the medications. The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. There is evidence that an educational brochure significantly increases proper disposal rates, albeit only to about 25%. The goal of this study is to evaluate the impact of an educational pamphlet on proper opioid disposal in the total joint arthoplasty population, and to see if the addition of a text messaging system can increase further increase proper disposal rates.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing primary total hip or knee arthroplasty
* Age ≥18 years old

Exclusion Criteria:

* Patients allergic to oxycodone
* Patients consuming opioids during the 4 weeks prior to surgery
* Patients with a history of opioid dependence
* Patients undergoing revision total knee or hip arthroplasty
* Non-English speaking patients
* Age \<18 years old
Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections

The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.


Eligibility Criteria:
Inclusion Criteria:

* Post-menarche women and premenopausal women, between 18 and 50 years old;
* Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixed vaginal infection;
* Patients who have regular menstrual cycles (patients with regular menstrual cycles with intervals between 21 to 35 days, duration of 1 to 7 days)

Exclusion Criteria:

* Patients who have a known hypersensitivity to components of the formula ;
* Pregnant and lactating women ;
* Patients with other vaginal infections, such as infection by Trichomonas vaginalis , C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.
* Knowledge of positive test result for human immunodeficiency virus ;
* Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;
* Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;
* Patients with other vaginal or vulvar conditions that may confound interpretation of clinical response;
* Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14 days before randomization ;
* Patients on immunosuppressive medications (such as corticosteroids , cyclosporine , etc. ) ;
* Known or suspected cancer ;
* Participation in any experimental study or ingestion of any experimental drug 12 months before the start of this study.
Breast Ultrasound Image Reviewed With Assistance of Deep Learning Algorithms

This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence will help the Radiologist make more accurate diagnoses.

Using ultrasound images prospectively acquired, the purpose of this study entails a second review of ultrasound images with suspicious breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by SamsungMedison Co.,Ltd.

The images will be reviewed by the radiologists twice: first without, and then with assistance of artificial intelligence program by SamsungMedison Co., Ltd.

BIRADS system will be used in this study.

The objectives of the study are twofold: to quantify the statistical equivalence of radiologists' opinion and AI's output (CADe), and to check BIRADS score-based diagnostic accuracy (CADx) that is gained by the Radiologists' use of this interactive tool

Eligibility Criteria:
1. Inclusion Criteria:

   * Adult females or males recommended for ultrasound-guided breast lesion biopsy or ultrasound follow-up with at least one suspicious lesion
   * Age \> 18 years
   * Able to provide informed consent
2. Exclusion Criteria:

   * Unable to read and understand English
   * Unable or unwilling to provide informed consent
   * A patient with current or previous diagnosis of breast cancer in the same quadrant
   * Unable or unwilling to undergo study procedures
3. Subject Characteristics

   1. Number of Subjects: 300 subjects from 300 separate breast lesions can be acquired. If a subject has more than 1 suspicious lesion, each may be chosen by the radiologist attending as suitable for "second review".
   2. Gender and Age of Subjects: Adult females or males aged 18 years or older who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment. Minors are excluded as breast cancer is very rare in this age group.
   3. Racial and Ethnic Origin: There are no enrollment exclusions based on economic status, race, or ethnicity. Based on local and United States census data, the expected ethnic distribution will be approximately 26 Hispanic (approx. 16%) and 134 non-Hispanic people. Furthermore, the expected racial distribution is expected to be approximately 126 White (approx. 79% of the whole study), 21 Black or African America (13%), 8 Asian (5%), and 5 of other categories (3%).
   4. Vulnerable Subjects: It is unlikely that any UR students or employees will be enrolled unless their primary physician refers them to UR Medicine Breast Imaging at Red Creek for breast ultrasound and a suspicious lesion is found. We do not expect any of these referrals to be from staffs who work directly with the PIs.
Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies
2. Aged 18 years or older
3. Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.
4. Patients must have the ability to understand and willingness to sign an informed consent document.

Exclusion Criteria:

-
A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion

The primary aim of this study is to investigate how a physical activity counselor can offer an added value in the sports and exercise promotion in Flanders. The investigators will explore if the physical activity counselor, in collaboration with the setting of general practitioners and social-cultural associations, can refer sedentary people and persons who are active in a non-organized context, into systematic participation in sports and/or exercise. Additionally, the investigators want to determine if the physical activity counselor will succeed in referring the target population to the local supervised and structured sports and exercise activities.

Being regularly physically active is a basic component of a healthy lifestyle. However, a large amount of the Flemish population does not reach the prescribed guidelines and cannot enjoy the health benefits related to an active lifestyle. One part of the population is physically active but makes no use of the existing, structured and supervised exercise and sports programs. Therefore the chance on lifetime participation in sports and exercise is quite low in this group. Another group consists of sedentary people that does not participate in any exercise or sports activity at all.

A physical activity counselor can possibly deliver a crucial service for the above mentioned groups. He/she can design an individualized sports- or exercise approach and program. In the short term, the physical activity counselor can guide the participant into his first success experiences regarding exercise and sports. In the long term, the chance of remaining physically active will increase by improving the understanding and the self-confidence of these participants.

However it is questioned how the physical activity counselor can reach these target groups in an efficient way, as the traditional sports and exercise promotion seems to have no impact on these persons. A first alternative may be the setting of the general practitioners. The general practitioner is, as a care provider in primary health care, in a good position to refer sedentary people or those who are active in a non-organized context to a physical activity counselor for 'minimal' coaching. A second alternative can be the setting of the social-cultural associations (e.g. seniors association, women association, neighborhood actions, ...). The social context and the local networks in these associations facilitate the proper forms of motivation to exercise with other people and to adapt to a healthy lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-75 years of age
* Able to walk

Exclusion Criteria:

* Severe cardial disease
Complementary and Alternative Care in Multiple Sclerosis

This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary progressive MS, primary progressive MS, clinically isolated syndromes (CIS), radiologically-isolated syndromes (RIS), possible MS, or probable MS.
* Age 18-100

Exclusion Criteria:

* Inability to read/write in English
* Inability or unwillingness to complete surveys every six (6) months. (\~ 90 min)
eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study

Introduction: Due to the worldwide ageing population and the increasing prevalence of chronic illnesses and cognitive deficits, appropriate instruments for frailty early screening and assessment of geriatric syndromes are required. Digital tools based on artificial intelligence can help improve the evaluation and screening of health risks in the older adults.

Objectives: This study aims to evaluate the effectiveness of the PRESAGE CARE questionnaire in screening geriatric syndromes among older adults and to assess its correlation with standardized test scores of the comprehensive geriatric assessment (CGA).

Methods: A monocentric prospective observational study will be conducted between October 2023 and July 2024, on seniors who are in the day hospitalization service of Charles-Foix hospital in France. During the consultation with older adults, the investigators will ask the patient's home caregiver to use the PRESAGE CARE application to fill in the PRESAGE CARE questionnaire. Once the questionnaire will be completed on the application, the PRESAGE platform will automatically recorde specific risks for each senior. Subsequently, the investigators will retrieve the data from standardized tests conduct on the same day and enter the results for each patient into the platform.

The primary outcome will be the correlation between standardized test scores and the risks computed by the Presage Care system for the risk of depression, the risk of undernutrition, the risk of cognitive impairment and the risk of loss of autonomy in activities of daily living.

Secondary outcome will be the comparison of the Area Under the Median Curve (AUC), and the sensitivity, specificity and positive predictive values of artificial intelligence (AI)-based models on the Présage Care questionnaire.

During the consultation and the assessment of the older adult by the physicians and the nurses at the day hospitalization service of the hospital, patient's relative fill out PRESAGE CARE questionnaire. Then, the investigators retrieved the data from the standardized tests completed the same day by the health professionals and filled in the test results for each patient on the platform.

Eligibility Criteria:
* Inclusion criteria :

  1. family members of individuals aged 65 and above,
  2. who are present within the day hospitalization service of Charles-Foix Hospital
  3. and able to provide informed consent.
* Non inclusion criteria

  1. refuse to give their consent to participate in the study,
  2. or have cognitive impairments
  3. or are occasional caregivers.