cyrilzakka/clinical-trials huggingface dataset:
Web-Based Communication Education for Breast Cancer Survivorship Care

This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.

This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization.

Eligibility Criteria:
Inclusion Criteria:

Eligible Chinese women

* ≥ age 18
* foreign-born speaking Mandarin and/or Cantonese,
* diagnosed with breast cancer at stage 0, I, II or III,
* 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and
* no recurrence, and 6) internet access.

Exclusion Criteria:

* Women with other cancer types are ineligible due to different treatment complications.
Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.

Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for the removal of renal stones by percutaneous
* nephrolithotomy (PCNL)
* ASA I-II status

Exclusion Criteria:

* Respiratory or cardiac disfunction
* Neuropathy
* Coagulopathy
* BMI (Body mass index)over 30
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to \<4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset seizure frequency and that pregabalin will be safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have 3 partial onset seizures in the month prior to screening.
* Subject must have 2 partial onset seizures during the 48 hour baseline phase.
* Signed Informed Consent.
* On 1-3 stable anti-epileptic drugs at screening.

Exclusion Criteria:

* Primary generalized seizures including clonic, tonic, clonic-tonic, absence, febrile seizures, and infantile spasms.
* Lennox-Gasteau, BECTS, and Dravet's syndrome.
* Status epliepticus within 1 year of screening.
* Any change in AED regimen with 7 days of screening.
* Progressive structural central nervous system (CNS) lesion or a progressive encephalopathy.
* Progressive errors of metabolism.
A Study of the Effectiveness of Cognitive Adaptation Training in Early Intervention for Psychosis

The proposed study will involve a randomized trial of Cognitive Adaptation Training (CAT) for early intervention as compared against an active control in which Action Based Cognitive Remediation (ABCR) will be applied.

The proposed project will expand knowledge of the role of compensatory and restorative cognitive interventions for early intervention population individuals with schizophrenia. The investigators will conduct a two arm randomized trial comparing the impacts of CAT and Action Based Cognitive Remediation (ABCR) for individuals with schizophrenia who are under the age of 30. The model would mirror the investigators' preliminary work at CAMH (Kidd et al., 2014) in which there will be 4 months of specialist-delivered treatment followed by 5 months of maintenance by case managers with pre, 4 month, and 9 month evaluations conducted. This study will be among the most rigorous examinations of such interventions to date, would be among the first to examine integrative approaches, and would make a substantial contribution to the early intervention literature.

The questions for the purposes of this project are:

1. Is CAT effective among individuals with schizophrenia under the age of 30?

   and
2. Does integrating cognitive remediation with CAT enhance outcomes as compared with CAT alone?

Eligibility Criteria:
Inclusion Criteria:

* Participants must be CAMH clients, have an assigned caseworker, be between the ages of 16-34 and have a psychosis such as schizophrenia or schizoaffective disorder.

Exclusion Criteria:

* not currently experiencing high level of paranoia.
Pragmatic Factorial Cluster Trial of Framing and Comparators for Audit and Feedback

Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO currently conducts audit and feedback as a key quality improvement strategy. For example, it offers physicians working in long-term care homes with access to practice reports detailing rates of high-risk prescribing in comparison with others in Ontario and suggested change ideas. Research shows that providing this kind of feedback can lead to improvements in care. However, the size of these improvements depends how the feedback is presented. For instance, prior research suggests that how the results are 'framed' and what sort of benchmark the recipient is compared to may each affect how the physician will respond. This factorial trial tests each of these aspects of feedback design in the context of practice reports that nursing home physicians have already signed up to receive quarterly.


Eligibility Criteria:
Inclusion Criteria:

* a physician licensed by the College of Physicians and Surgeons of Ontario (CPSO);
* practice in at least one LTC facility in Ontario;.
* have voluntarily signed up to receive an HQO practice report

Exclusion Criteria:

* n/a
Feasibility of a Novel, Theory Based Physical Activity Intervention Among Adult Cancer Survivors

As the number of cancer survivors grows and expected survival time increases, the health behaviors of this population are gaining significant attention from the research and public health community. Adoption or maintenance of healthy lifestyles after cancer has the potential to reduce both cancer- and non-cancer-related morbidity and mortality. Exercise adoption and maintenance remains a significant challenge for adults, especially clinical populations such as cancer survivors who may struggle with comorbidities, symptoms and side-effects of the disease or medications, and overall compromised health and functioning. A number of site-based exercise interventions have been conducted to promote physical activity, often using a theoretical basis to design and execute the intervention. Although these programs are successful in exposing cancer survivors to regular physical activity, they often struggle with exercise maintenance after the conclusion of the structured site-based group exercise sessions. The goal of the proposed project is to enhance physical activity engagement among adult cancer survivors by designing a home-based program using the socio-ecological framework and employing constructs from social cognitive theory to guide participants through the project.


Eligibility Criteria:
Inclusion Criteria:

* 30-75 years of age at baseline
* Cancer diagnosis during adulthood (no childhood cancers)
* Low-active (≤ 2 days of 30 minutes of structured exercise/week)
* At least 1 month since last cancer treatment (surgery, chemotherapy and/or radiation)
* No reservations from a doctor/physician/oncologist to engage in physical activity
* Not currently undergoing cancer-related treatment
* No active cancer diagnosis
* Willingness to participate in a 12-week home exercise program
* Willingness to be randomized to either the 12-week home exercise or a 12 week education group
* Access to a laptop/ phone with Zoom web-conferencing software
* An active email address to receive and sign the electronic informed consent
* Willingness to complete study questionnaires before and after the 12-week program, and 3 months after the program
* Fluency in English

Exclusion Criteria:

* Below 30 or above 75 of age at baseline
* Childhood cancer diagnosis only
* High active (\> 2 days of 30 minutes of structured exercise/week)
* Cancer treatment within the last month or currently undergoing treatment
* Advised to refrain from physical activity by a doctor/physician/oncologist
* Active cancer diagnosis
* Not willing to participate in a 12-week home exercise group and/or complete study assessments
* Not willing to be randomized into one of the two study groups
* No access to a laptop/phone with Zoom software
* No access to active email
* Not fluent in English
Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver

The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)

The MicroKid project will acts first as a case-control study (Study I) in order to identify the hepatic steatosis and intestinal and salivary microbiota in children grouped as non-overweight, obese-non-hepatic steatosis, and obese-hepatic steatosis. Then, an intervention study (Study II) will be developed for those children with obesity (i.e., obese-non-hepatic steatosis, and obese-hepatic steatosis groups).

Methodology: A total of 60 children, 8-12 years-old, will be assigned to control (non-overweight children, N= 20), obese-non-hepatic steatosis (children with obesity, but without hepatic steatosis, N=20), and obese-hepatic steatosis (children with obesity and hepatic steatosis, N= 20) groups (Study I: case-control study). The obesity and obesity + hepatic steatosis groups will attend to a 12-weeks healthy lifestyle education program (2 days/month) and home-based exercise program (minimum 3 days/week) (Study II: intervention study).

The combined intervention program for the Study II will include: i) healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and ii) exercise program based on high-intensity interval training which combines aerobic and resistance training (at least 3 days/week, from 38 to 44 min).

Measurements: In the Study I (i.e., case-control study), all participants will be evaluated at baseline. For the Study II (i.e., intervention study), only those participants that belongs to obese-non-hepatic steatosis and obese-hepatic steatosis groups, will be additionally evaluated after the intervention program (12-week). The following outcomes will be measured: hepatic fat fraction and abdominal adiposity (magnetic resonance imaging), intestinal and salivary microbiota, body composition (bioimpedance), cardiometabolic risk factors, liver enzymes, physical fitness (field-fitness tests), physical activity (accelerometry), sleep (accelerometry), dietary habits (24h recalls, and food frequency questionnaires), and pubertal development and sociodemographic characteristics will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Obesity defined based on the sex-and-age specific body mass index standards
* 8-12 years old

Exclusion Criteria:

* Medical conditions that hamper their participation in the exercise program
Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station

The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.

While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.

The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 7 years
* informed consent
* Member of target group: Visitor or staff

Exclusion Criteria:

* Insufficient language skills
Sperm Video Recording Protocol

The purpose of this study is to obtain anonymous video clips of male semen at high magnification, to manually select out of the video spermatozoon images, and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS™ Fertility System. The study will enroll males attending the clinic who may elect to contribute their unused excess sample materials from semen analysis or IVF/ICSI (Intracytoplasmic sperm injection) which is a technique used during in vitro fertilization (IVF).

The study will obtain video clips of 40 male subjects semen sample at high magnification. Each subject contributes 1 sample from which 10 minutes of video is recorded.

A total of 720,000 frames are expected to be collected at 30 frames per second. At least 6,000 frames will be selected at random from these 10,800-14,500 frames to be labeled by at least two embryologists. The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition. The data collected will be utilized to train the Artificial Intelligence (AI) used within the BAIBYS System.

Eligibility Criteria:
Inclusion Criteria:

* Assigned male at birth and possessing typical male anatomy (i.e., one or two testicles and penis)
* Scheduled to produce a semen sample for fertility evaluation
* Able to produce a semen sample, including, in the judgement of the PI, ability to follow instructions provided in English by the physician or physician's team members
* At least a 10th grade education level, to be able to read and understand the ICF; evaluated by either completion of 10th grade, or by any higher level of education or GED
* Age 22 or older at the time of consent

Exclusion Criteria:

* Known azoospermia prior to semen analysis.
* Subjects with azoospermia or otherwise inadequate sample discovered during the trial will be compensated for their participation in recognition of their efforts to contribute to science, but will be replaced with an additional subject for the data collection and labeling to reach a total sample of up to 40 videos
* History of chemotherapy or radiation within prior 12 months, due to increased chance of azoospermia
* Developmental delays or other neurological impairment that could impair ability to freely consent, as evaluated by the PI
* Any reason why in the sole judgement of the PI, consent to participate cannot be freely given
Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.

The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial in adults (≥18 years) who are mechanically ventilated in the ICU with risk factors for LE and an order to extubate has been provided by the treating physician.

The aims of this study are to assess:

1. Protocol adherence
2. Recruitment rates
3. Secondary clinical outcomes will be collected, and if feasibility criteria are met, ultimately used in the powered trial pending no major protocol adjustments (otherwise will be reported as cohort data).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 yrs. of age
* Mechanically ventilated in the ICU \\
* An order to extubate has been provided by the treating physician
* Meet at least 1 criteria for risk factors for Laryngeal Edema(LE):
* Criteria 1
* Intubated for \>5 days
* Criteria 2 \*must fulfill category 1 and ≥1 risk factor in category 2
* Category 1

  - Intubated for \>48 hours
* Category 2

  * An unplanned extubation event within the last week
  * Airway trauma secondary to an endotracheal intubation during the past week defined as one of the following:
  * More than one attempt at direct laryngoscopy
  * More than one attempt to pass the ETT
  * Charted as a traumatic intubation
* A body mass index of \>30kg/m2
* An endotracheal tube greater than 8mm in a man or 7mm in a woman
* A total positive cumulative fluid balance of at least \>1500ml/d x # of days admitted to ICU (eg. If admitted for 4 days, the patient will meet this criterion if they are 6L positive during their length of ICU admission)
* Physician concern about possible laryngeal edema for a reason not previously listed above. For example:
* Prone or Trendelenburg position in a recent operation
* Agitation defined as a RASS of 3+ or more or a SAS of 6 or more that may result in airway injury

Exclusion Criteria:

* Palliative care plan or plan of care does not include re-intubation, Decision to withdraw life support, or no plan for re-intubation
* Known pregnancy: Current pregnancy or up to and including 7 days postpartum
* Patients with highly suspected laryngeal injury: Burn patients, smoke inhalation injuries, blunt or penetrating trauma of the neck and airway, recent head and neck surgeries, and patients admitted with airway edema
* Known pre-existing tracheolaryngeal abnormalities: Vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalasia, tracheolaryngeal stenosis, or previous head and neck surgeries
* Mechanical ventilation via a tracheostomy
* High dose steroids administered within the previous 72h (Prednisone 1mg/kg oral equivalent)
* The ICU physician believes the patient should have a CLT performed
* Patient had a failed CLT in the previous 24 hours
Addition of Phytosterols to a Low Phytosterol Diet

Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. This means that the effects of small amounts of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will examine the effects of phytosterols across a range of levels. The information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.


Eligibility Criteria:
Inclusion Criteria:

Men and women are eligible who:

* are of any race or ethnicity between 18 to 80 years of age;
* are in generally good health;
* have moderately elevated blood cholesterol(LDL cholesterol between 100 and 189 mg/dl)
* will eat only the foods that are provided by the center during the diet periods;
* will drink no more than 5 cups of caffeine-containing beverages a day;
* will consume no more than 1 alcoholic drink a day;
* will abstain from the consumption of alcohol for 48-hours prior to blood draw days

Exclusion Criteria:

* are younger than 18 or older than 80 years;
* have very high cholesterol(LDL cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl);
* have very high blood pressure(equal to or above 160 mm Hg systolic or 95 mm Hg diastolic);
* are overweight( BMI greater than 35 kg/m2)
* are taking lipid-lowering, or any other medication known to affect blood cholesterol;
* have diabetes mellitus, cancer, heart, liver and/or kidney disease, or chronic disease that might interfere with participation;