cyrilzakka/clinical-trials huggingface dataset:
New Medication Treatment for Stimulant Dependence

This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.

Eligibility Criteria:
Inclusion Criteria:

* Males and females who have given written informed consent.
* Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
* Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
* Current DSM-IV diagnosis of cocaine dependence.
* At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
* The pregnancy test for females at intake must be negative.
* Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
* Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
* Willing to participate in behavioral treatments for cocaine dependence.

Exclusion Criteria:

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Social Relations Training for Children With ASD

The following protocol was developed with the intention of significantly improving social skills by focusing on increasing relationship skills among children with ASD. Divided into two distinct parts, "Basic Social Relationships" and "Intermediate Social Relationships," the protocol has 4 stages for the former and 5 stages for the latter. Each phase is preparatory to the next, and in addition, a teaching procedure is implemented that adopts three prompt levels (partial, moderate and total), gradually aiming to reduce the assistance provided to encourage independent response. This gradual approach is designed to stimulate greater independence in social interactions.

The training lasts between 6 and 12 months, with one or two weekly group meetings lasting forty-five minutes each. Before the start and at the end of the protocol, participants are assessed using the Vineland scale to evaluate their adaptive behaviors.

The primary goal is to enable children with autism to develop meaningful social skills, providing them with concrete tools to interact more effectively and independently with their peers, thus improving their quality of life and social involvement. The protocol involves two distinct groups, experimental and control group.

The experimental group involves the use of a social robot that acts as a mediator in the interactions among participants. The role of the social robot is to facilitate, reinforce and support the participants' responses during the activities. The therapist coordinates with the social robot, helping to guide, reinforce and support participants' interactions.

In the control group, the therapist takes on the role of mediating interactions, helping and facilitating participants' responses. There is no involvement of a social robot; therefore,the therapist self acts directly to guide, reinforce and support the participants' social interactions.


Eligibility Criteria:
Inclusion Criteria:

* language in sentences
* Griffiths: QS\>75

Exclusion Criteria:

* presence of other medical disorders
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. It is agreed that all patients should receive premedication with dexamethasone, an H1 antagonist, such as diphenhydramine, and an H2 antagonist before the administration of paclitaxel. There are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. Diphenhydramine is often accused because of its pharmacological properties.

A definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating H1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions.

In the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. The goal is to explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Eligibility Criteria:
Inclusion Criteria:

* Receiving intravenous chemotherapy treatments at the Maisonneuve-Rosemont hospital outpatient oncology clinic
* Starting their first lifetime treatment with paclitaxel (alone or in combination with other anticancer agents).
* Capable of giving free and informed consent and who agrees to participate by signing the consent form
* Aged 18 and over
* Able to complete questionnaires

Exclusion Criteria:

* Does not understand French or English
* Taking chronic H1 antagonist orally
* Taking chronic systemic corticosteroids
* Contraindication or possible medical danger, such as a documented allergy or previous intolerance, related to the administration of cetirizine, diphenhydramine, placebo or any ingredient in their formulation
* Has received paclitaxel, docetaxel or paclitaxel nanoparticles linked to albumin in the past
* Receiving paclitaxel nanoparticles linked to albumin
* Severe renal impairment (Cockcroft-Gault \<10 milliliters/minute)
* Pregnant or breastfeeding women
* Receiving paclitaxel under desensitization protocol
* Documented or reported dysphagia or other pathophysiological condition preventing a tablet from being swallowed whole
* Interactions preventing the full dose of oral cetirizine from being absorbed
* Participating in another clinical trial simultaneously
BMI-Associated Labor Induction: A Prospective Trial

The primary objective of this study is to determine if planned induction of labor at 39 weeks for nulliparous with pre-pregnancy BMI ≥ 35 kg/m2 reduces the incidence of cesarean section compared to expectant management

Obesity in the obstetric population has reached epidemic proportions, affecting over 30% of reproductive-aged women in the United States (1). The increase in this morbidity is associated with large increases in cesarean delivery over the non-obese obstetric population and resultant post-operative complications are also higher in obese women (2). There are no interventions proven to reduce the risk of cesarean in obese women. The aim of this research study is to determine if induction of labor at 39 weeks can reduce the incidence of cesarean delivery over routine obstetric care (expectant management).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. Pregnant, singleton gestation, vertex presentation
3. Nulliparous (no prior pregnancy delivered past 20 weeks)
4. Pre-pregnancy (self-reported in record of in EMR within 3 months of LMP) or 1st trimester (up to and including 14 weeks 0 days) BMI ≥ 35 kg/m2
5. Gestational age at enrollment 38 weeks 0 days and 38 weeks 6 days with dating confirmed by LMP and ultrasound performed prior to 20 6/7 weeks

Exclusion Criteria:

1. Plan for induction of labor prior to 41 weeks 0 days for medical indication prior to study consideration
2. Plan for cesarean delivery or contraindication to labor
3. Major illness with increased risk of adverse pregnancy outcomes (e.g. pregestational diabetes with or without medication, gestational diabetes on medication, hypertension, cardiac disease, renal insufficiency, autoimmune disorder)
4. Multiple gestation
5. Non-vertex presentation
6. Fetal death
7. Fetus with major/lethal anomaly or aneuploidy (soft markers of aneuploidy, urinary tract dilation, isolated bowel dilation, mild ventriculomegaly, normal variants of vascular system, and isolated ventricular septal defects will not be excluded)

   a. Soft markers not qualifying as exclusion criteria: echogenic intracardiac focus, choroid plexus cyst, echogenic bowel, increased NT or nuchal fold, isolate short humerus or femur
8. Fetal growth restriction (EFW \<10th percentile or AC \<10th percentile)
9. Preeclampsia or gestational hypertension
10. Known oligohydramnios or polyhydramnios
11. Prior delivery after 20 weeks
12. Placenta/vasa previa
13. Placental abruption (known or suspected) or unexplained vaginal bleeding
14. Previous cesarean section, myomectomy, or classical cesarean
15. Spontaneous labor or suspicion of labor with regular contractions and cervical change, rupture membranes
16. Active genital herpes or HIV positive
17. Inability to consent
18. Any contraindication to a vaginal delivery
19. Delivery anticipated outside of Baystate Medical Center
Contrast Ultrasound in the Surveillance of Endovascular Abdominal Aortic Aneurysm Repair

The purpose of this study is to support the suspected expectation that Contrast enhanced Ultrasound (CUS) detects all endoleaks that have been detected by Computed Tomography (CT), and also find a number of leaks missed by CT.

The investigators' primary goal is to detect no difference between CT and CUS and provide evidence that CUS is a possible alternative to CT.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent EVAR at The Ottawa Hospital and currently under post-EVAR surveillance at The Ottawa Hospital.

Exclusion Criteria:

* Unable to consent for injection of contrast
* Unable to acquire IV access
* Right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Severe pulmonary disease
* Previous hypersensitivity to DEFINITY® or its components
* Unable to be followed as a outpatient by the Vascular Diagnostic Center
Effects of Early Mobility Protocols in Cardiac ICU

In this study the investigator aim to find the effects of early mobility on different physical activity protocols in post CABG patients. Physical activity, functional status, functional capacity, Kinesiophobia, ICU mortality, heart rate, blood pressure, oxygen saturation, length of hospital stay and sternal instability. To compare the physical activity protocol used by physical therapist.

Current study will compare two different early mobility protocols and will help in assessing best protocol to be use in cardiac ICU for better outcomes of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 years
* Both Genders
* Extubated patients with no Complication
* Post CABG (Elective)
* Vitally stable
* 1st CABG
* Selective CABG surgeries

Exclusion Criteria:

* Post anesthesia Psychosis
* Corrective surgeries
* Post CABG Stroke
* Infectious wound
* Participants with a physical disability
* Intra-aortic balloon pump (IABP)
Impact of a Physical Exercise Program in a Rural Area

With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. another group (G2) newly introduced to the same exercise program, and a control group (G3) that does not carry out an exercise program but declared itself active.

Active aging, according to the World Health Organization (WHO), involves making the most of everything that contributes to physical, mental and social well-being throughout life, thus promoting improved quality of life, functionality and longevity in the most advanced stages of life, seeking to minimize disability. To achieve active aging, older people must remain active in all aspects: physical, social and mental. For this reason, the WHO recommends that older adults engage in moderate to vigorous physical activity (MVPA) of 150 minutes a week The objetive, To assess whether there are differences in the amount of MVPA per week, measured by accelerometry in 3 groups of subjects, where one group (G1) had been carrying out a PA program called "Enguera Sé Saludable" for a year, another group (G2 ) newly inserted into the same exercise program, and a control group (G3) that did not carry out an exercise program but declared itself active.

Analytical quasi-experimental study, with 3 groups. A group (G1) over 59 years of age, of both sexes who have been doing PA since the year before the start of the study, within the "Enguera Be Healthy" Program in the municipality of Enguera. Another group (G2) of both sexes, newly enrolled in the same exercise program over 59 years of age. A control group (G3) of 59 years of both sexes who do not carry out the exercise program, inhabitants of Enguera and apparently active. The data analyzed was obtained from the placement of an Actigraph model GT3X BT accelerometer for a week and the collection of data from the various instruments such as the measurement of blood pressure and weight using the Tanita BC Scale. -545N, the Tinetti scale, the Time Up \& Go test, the Monopodal Test, the SPPB test, the Sit to Stand Test, the Borg scale, the IPAQ questionnaire and the FHSQ questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 59 years of age.
* Patients who comply with accelerometer times for 7 days.
* Patients who correctly complete the accelerometer registration sheet.
* Patients who complete the informed consent

Exclusion Criteria:

* Patients who do not wear the accelerometer 600 minutes a day for at least 3 days on weekdays and 480 minutes for at least 1 day on the weekend.
* Patients who suffer from illness during data collection.
* Patients who do not wear the accelerometer for 7 days. Be in IPAQ category 1 (low level of AF).
A Comprehensive Disease Management Program for Medically-Complex Substance Users

Disease management (DM) programs are being increasingly utilized by health plans to coordinate care, improve quality of care, and control costs in chronically ill individuals. DM programs for specific medical conditions, such as diabetes mellitus, congestive heart failure, and asthma, have demonstrated improvements in health outcomes and a number of studies have found economic benefits to these programs as well. There are fewer data evaluating multi-disease DM programs, and results have been mixed. Additionally, data on such programs specifically targeting substance-using populations are limited, although they are promising. Prior utilization and hospitalization data from Johns Hopkins Hospital, Johns Hopkins Health Care, and Priority Partners Managed Care Organization (PPMCO) suggest that a substantial portion of high-utilizing, high-cost, medically complex patients have a substance use diagnosis.

The investigators hypothesize that a comprehensive DM program for medically-complex substance users with a history of hospitalization, consisting of intensive nurse case management along with behavioral incentives to reinforce engagement in primary care, can decrease inpatient days and costs, as well as improve outcomes for substance use, depression, and physical and mental functioning. The investigators will compare the case management/behavioral incentives intervention to usual care among a group of medically-complex, substance-using, PPMCO enrollees. Usual care will include access to all existing Priority Partners care management programs, and usual The investigators believe that this research will make an important contribution to the development of models of chronic care that improve health and promote the best use of health care resources. Additionally, the investigators believe this project will promote the study and development of systems to improve the health of substance-using adults, an underserved and often marginalized group.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Continuous enrollment in Priority Partners MCO for past 12 months
* Primary care site East Baltimore Medical Center (EBMC)
* PPMCO substance abuse flag other than nicotine only within past 24 months

Exclusion Criteria:

* currently enrolled in PPMCO Care Management
Predictors of Unsuccessful Endoscopic Mucosal Resection of Complex Colon Polyps

A prospective outcomes study in patients referred for endoscopic mucosal resection of complex colon polyps.

Colon cancer is the third leading cause of cancer-related death in the United States. The number of these deaths has significantly decreased due to screening colonoscopies. A colonoscopy is a procedure in which a physician examines the rectum and large intestines for abnormalities through the use of a specialized camera called an endoscope. Colonoscopies decrease the mortality associated with colon cancer through two main ways: by detecting and removing pre-cancerous lesions called polyps; and by detecting colon cancer at earlier stage, when therapies can still be effective at treating or removing the cancer.

Most colon polyps are small and can be completely removed during a standard colonoscopy. However, there is a growing awareness amongst endoscopists of polyps that are too large or inaccessible to be safely removed during a routine colonoscopy. Previously, these lesions required surgery for removal of the affected part of the colon. There is a growing body of evidence that suggests these more complex colon polyps can be entirely removed endoscopically through a procedure called endoscopic mucosal resection (EMR), thereby avoiding costly and debilitating surgery. Given that it is a novel procedure, it is only available at specialized care centers.

EMR is a procedure identical to a colonoscopy, with more steps involved in the lifting and removal of complex polyps. As many as 80-90% of complex polyps can be successfully removed with EMR. However, it has been noted that removal of the polyp in pieces, rather than as a whole can result in a 20-30% recurrence rate at the resection site. Any manipulation of the polyp prior to EMR may impair the ability to fully remove the lesion. Some factors that have previously been suggested to increase the difficulty of EMR include previous dye injections, removal attempts, and polyp sampling. However, the true impact of previous manipulations of CCPs remains unclear.

This study aims to be one of the largest prospective, multi-centered studies investigating factors that predict the failure of EMR in the removal of complex colon polyps.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred to each of the participating tertiary care centers for endoscopic mucosal resection (EMR)

Exclusion Criteria:

* Does not meet inclusion criteria
Physical Activity and Disability Prevention in Postmenopausal Women

The aim of this clinical study is to examine the impact of physical activity on the physical and mental health of postmenopausal women, with a particular focus on the development of disability. The main questions this study aims to answer are:

1. Can physical activity programs (Nordic walking, Bungy Pump, strength training, functional general conditioning training) prevent loss of mobility, bone density and urinary incontinence, reduce the risk of falls, lower metabolic syndrome parameters, and improve cardiovascular endurance in postmenopausal women?
2. Do regular exercises improve cognitive functions, motivation, memory, visual coordination, mood, and quality of life in postmenopausal women?

Researchers will compare the test groups (Nordic Walking, Bungy Pump, strength training, functional general conditioning training) with the control group to determine whether physical activity brings benefits in terms of physical and mental health compared to no intervention.

Participants will:

Take part in a three-month physical activity program that includes Nordic walking, Bungy Pump exercises, functional general conditioning training and strength training, depending on the group.

The control group will not participate in any additional physical exercise program and will continue with their usual daily activities.

This study will involve two testing phases (pre- and post-training). Prior to the first test, participants' physical activity will be measured over a period of seven days using POLAR accelerometers to evaluate the relationship between their daily physical activity and health. Each testing phase will last two days; on the first day, blood samples will be collected, and preliminary analyses of body composition and dietary records will be conducted. On the second day, physical fitness tests and psychological test swill be performed at the AWFiS Sports Exercise Laboratory in Gdańsk. Biological materials (serum) will be frozen and subsequently tested by contractors at the AWFiS Sports Genetics Laboratory. Participants will be required to maintain a dietary diary to record their dietary intake for the three days preceding the tests.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women over 60 years old (i.e. more than 12 months since their last menstrual cycle).

There were no contraindications to exercise after case reports and initial diagnosis.

Informed consent must be signed, agreeing to participate in research and physical exercise programs.

Exclusion Criteria:

* Uncontrolled high blood pressure. Rheumatoid arthritis. Type 2 diabetes. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.