cyrilzakka/clinical-trials huggingface dataset:
Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations

A cluster randomized trial will be conducted prior to widespread vaccine availability to the general public. Community-informed COVID-19 vaccine messages will be disseminated to participants. At baseline, 2 weeks and 4 weeks, the study team will survey participants to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.

A cluster randomized trial with 80 participants from the social networks of 8 CLs will be conducted prior to widespread vaccine availability to the general public. Four CLs and social networks (cluster of 10 per network) will be randomly assigned to receive the intervention immediately or after a delay of 2 weeks. Intervention participants will be invited to a closed social media group on the platform of their choice. CLs, selected for trustworthiness within vulnerable populations, will disseminate community-informed COVID-19 vaccine messages to members of their social networks and engage in bidirectional communication with CEnR partners to refine messages. At baseline, 2 weeks and 4 weeks, participants will be surveyed to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.

Eligibility Criteria:
Inclusion Criteria:

* Self-identification within a CLs social network
* Age 18 or greater
* Functional internet access.

Exclusion Criteria:

* Does not self-identify within a CLs social network
* Is under the age of 18
* Does not have functional internet access.
Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent for persistent high-grade NMIBC Ta/T1/Tis (Ta/T1 with CIS is preferred, but not required) within 24 months of the last treatment with BCG (with or without IFN)

  o Up to 26 months from the last BCG treatment is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence of recurrent disease (by positive cytology, imaging, or office cystoscopy) within 24 months of last BCG transurethral resection of bladder tumor (TURBT)
* Pathologic confirmation of stage, grade, and urothelial histology by the Department of Pathology at MSK
* All visible papillary lesions macroscopically resected within 60 days of treatment initiation
* Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment
* Receipt of restaging transurethral resection (TUR) for any tumor with invasion into the lamina propria (HGT1) as part of standard care
* Age ≥18 years
* Karnofsky performance status ≥60%
* Informed consent

Exclusion Criteria:

* Positive pregnancy test
* Known contraindications to BCG

  * History of systemic hypersensitivity reaction or history of febrile systemic BCG reaction
  * Febrile illness or persistent gross hematuria
  * Active tuberculosis
  * Immunosuppression due to congenital or acquired immune deficiency, concurrent immune suppressive disease, systemic cancer therapy, or chronic immunosuppressive therapy other than topical or inhaled corticosteroids
* History of or currently being treated for muscle-invasive (i.e., stage T2 or higher) or metastatic urothelial cell carcinoma
* Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma
* BCG-unresponsive NMIBC as defined by the FDA:

  * HGT1 within 3 months after an induction BCG course (received ≥5 of 6 doses)
  * Persistent or recurrent high-grade NMIBC (Tis, Ta, T1) within 6 months of ≥5 of 6 doses of induction BCG therapy and ≥2 of 3 doses of maintenance BCG therapy
The Effect of Microneedling With Low Energy Laser in Androgenic Alopecia Patients.

Androgenetic alopecia is the most common type of hair loss in men, and affects approximately 50 percent of Caucasian men by age 50. The condition is characterized by the progressive loss of terminal hairs on the scalp in a characteristic distribution. The anterior scalp, mid scalp, temporal scalp, and vertex of the scalp are typical sites of involvement. "Male balding" and "male pattern hair loss" are additional terms used to refer to this condition.

The aim of this study is to investigate the effect of microneedling in androgenic alopecia


Eligibility Criteria:
Inclusion Criteria:

- androgenic alopecia patients

Exclusion Criteria:

* infection, immune disorder, other dermatosis in treating areas
DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas

The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age at time of signing informed consent
* Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma

  * De novo diffuse large B-cell lymphoma (including all subtypes such as primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma). According to the 2008 WHO Classification of Hematopoietic and Lymphoid Tumors. These would include double or triple-hit diffuse large B-cell lymphomas with MYC/BCL2 and/or BCL6 gene rearrangements. These cases may be classified as high grade B-cell lymphomas according to the 2017 revision of the WHO Classification of Hematopoietic and Lymphoid Tumors.
* Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
* Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
* Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.

Exclusion Criteria:

* Patients receiving 2nd or greater line of therapy.
* Stage I or II disease.
* Primary mediastinal B-cell lymphoma.
* Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.
Internet Intervention Promotes Physical Activity in Sedentary Older Adults

This study evaluated the efficacy of a 12-week Internet intervention to help sedentary older adults adopt and maintain an exercise regimen. A total of 368 men and women over 55 years of age (x = 60.3; SD 4.9 ) were recruited and screened on line. They randomized into treatment and control groups and assessed at pre-test, 12 weeks, and at six months.

The multivariate model was significant at posttest (p = .001; large effect size) and at six months (p = .001; medium effect size). At posttest, intervention participation showed significant improvement on 13 of 14 outcome measures compared to the control group. At six months, treatment group participants were found to maintain large gains compared to the Ctrl participants on all 14 measures.

Based on the treatment group users self reported fitness level, activity goals, and self-identified barriers to exercise, the program helped users select exercise activities in the areas of endurance, flexibility, strengthening, and balance enhancement. They returned weekly for automated video and text support and education, with the option to change or increase in their exercise plan, and on-going problem solving to overcome barriers to exercise.

Eligibility Criteria:
Inclusion Criteria:

* \> 54 years of age;
* \< 61 minutes of exercise per week;
* internet connection; email address

Exclusion Criteria:

* too young;
* too active;
* no web access;
* no email
The Cascade Feasibility Pilot (Ileostomy)

Existing interventions including improving communication and self-care to improve readmission of patients undergoing high risk colorectal surgery involving new ileostomy formation has shown limited results. Our proposal is to deploy a wearable solution that predicts physiological perturbation with continuous remote patient monitoring and advanced machine learning algorithms which will be connected to structured, cascading, escalation pathways and care coordination involving home health nurses, colorectal and ostomy nurses, and colorectal surgeons, and has the potential to transform surgical management in the post-discharge period, where patients are the most vulnerable for readmission. This feasibility study will contribute to the understanding of post-discharge continuous remote monitoring of ileostomy patients, promote patient self-care, and has the potential of improving patient outcomes.

Colorectal surgery is a high-risk surgery that results in significant morbidity, and health care utilization in the form of readmission. Ileostomy creation is a significant risk factor in colorectal surgery rehospitalization. Effective continuous remote patient monitoring (CRPM) can reduce readmissions, but it has only been realized in select heart failure populations via invasive monitoring. The investigators will focus on colorectal CRPM in the elective, new ileostomy population through a structured cascading and escalating alert system. In this feasibility study, the investigators will use a wearable biosensor and collect ambulatory physiological data that are analyzed by machine learning algorithms, to generate personalized alerts of physiological perturbation in colorectal surgery patients in the post-discharge period. Alerts from this algorithm may be cascaded with other patient status data to inform management by the home health team via a structured protocol built into the electronic health record (EHR). The escalation pathway will engage home health nurses, colorectal care team nurses, ostomy nurses, and colorectal surgeons. The investigators will conduct surveys and semi-structured interviews with patients, and semi-structured interviews with providers, which will be used to evaluate the perceptions, acceptance, and experience of this CRPM solution.

Eligibility Criteria:
Inclusion Criteria:

* Patient is inpatient admission at NorthShore University HealthSystem hospital
* Patient underwent a new ileostomy formation at index hospitalization
* Patient is at least 18 years of age
* Patient is fluent in English
* Patient agrees to protocol-required procedures
* Patient discharges with NorthShore Home Health Service

Exclusion Criteria:

* Patient has cognitive or physical limitations that, in the investigator's opinion, limit the patient's ability to maintain patch device and phone
* Patient has allergy to hydrocolloid adhesives
* Patient has present skin damage preventing them from wearing a study device
* Pregnancy
* Patient discharge location is a Skilled Nursing Facility or other subacute facilities
Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial

The main objective is to determine the effectiveness of a multicomponent intervention for caregivers, conducted by an expert psychologist to improve the quality of life of the people with Alzheimer's disease. Secondarily, will be analyzed the effectiveness of this program on improving anxiety and depressive symptoms, burden, happiness, social support and cognitive performance of the caregivers and alleviate the behavioural and psychological symptoms of dementia (BPSD). The investigators analyze the caregiver's and patient's personality as a possible moderator between dependent and independent variables, and the resources utilization before and after intervention.

Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible participants will be 94 adult (≥18 years) caregivers of patients with Alzheimer's disease who follow-up by Osona Integrated Geriatric Unite (Catalonia, Spain).

The intervention group will receive a multicomponent intervention that includes dementia psychoeducation and management, emotional and communication skills, mindfulness and healthy lifestyle. The control group will follow the standard management according to the primary and specialized care professionals' team.

Main measurements: quality of life of the patients at baseline, after intervention and at six-month follow-up through QoL-AD. Secondary measures: they will be determined, at baseline, after the intervention and at six-month follow-up: depression (HDRS) and anxiety (HARS), burden (CBI), happiness (OHQ), quality of life (QoL-AD), social support (UCLA and DUKE-ANC), cognitive performance (neuropsychological assessment) of the caregivers, resources utilization (RUD), BPSD (NPI), cognitive status (MMSE), functional status (IADL) of the patients. Caregiver's personality at baseline and six-month follow-up and dementia characteristics at baseline will be measured. Other measures: sociodemographic and health characteristics of the caregivers and patients.


Eligibility Criteria:
Inclusion Criteria:

* adults (≥18 years of age)
* main caregivers of people with early or mild Alzheimer's disease
* follow-up by Osona Integrated Geriatric Unite (Catalonia)
* signed informed consent.

Exclusion Criteria:

* non stable medical condition the last six months (or any acute or chronic condition that would limit the ability of the patient to participate in the study)
* cognitive impairment (MMSE\<24)
* substance abuse
* active psychotherapy
* refusal to give informed consent
Moderate or Extensive Carbohydrate Reduction in Risk Patients

Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:

Randomization with regard to carbohydrate restriction (25-30 E% or \< 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.

Two-hundred patients are recruited and each patient is followed for two years.

The organizers will recruit 200 patients in the study "To lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (LOWinCHIP) at the primary care health center "Cithyhälsan Centrum" in Norrköping. Each patient will be followed for 2 years. Patients are eligible if they have are above 18 years of age and have a BMI above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) Patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. Finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. Patients must not have insulin therapy or severe kidney failure (GFR\< 30). They can also not have severe physical restrictions for activity and they must not have difficulties with understanding written Swedish texts.

The participants are randomized two times (two by two factorial):

Randomization with regard to carbohydrate restriction (25-30 E% or \< 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy (ACT) or to traditional cognitive behavioral therapy. Each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. Each session will be held by the psychologists that are part of the Cityhälsan Centrum staff.

The study has \> 95% power to demonstrate 5% HbA1c (mmol/mol) difference between groups with a drop out of 25%.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes without insulin. Patients at high risk for developing diabetes.

Exclusion Criteria:

* Severe kidney failure. Insulin therapy. Inability to understand instructions.
The Effect of Breastfeeding Support System

It is aimed to determine the effect of breastfeeding support system applied in newborns on developmental findings and discharge time.The research was planned as an experimental study with experimental and control groups. The population of the study consisted of babies who received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between February and June 2023. The sample of the study was calculated using the G\*Power computer program. In the calculation made, it was found that a total of 70 children, 35 of each for the control and experimental groups, should be included. In this study, the experimental group consisted of 36 children and the control group consisted of 35 children. Children selected by simple random sampling method were divided into groups by randomization and which group would be the experimental group and which group would be the control group were determined by randomization. Masking was done during data collection and data analysis. The data is in the analysis stage.

Breast milk is a natural food with high bioavailability, easy to digest, which reduces the morbidity and mortality of the newborn, contains all the fluid, energy and nutrients necessary for physical, spiritual and mental development.Breastfeeding has a biological and emotional impact on mother and baby, has many immunological, psychological, social and economic benefits for both mother and baby, and is the best method for maternal health and healthy growth and development of infants.The bond between mother and baby after birth In the sensitive period in which successful breastfeeding will be established by establishing a new hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for various reasons. During hospitalization, mothers cannot be with their babies during all feedings and often have to empty their breasts with a pump. The pump does not have the same physiological effect as breastfeeding on the milk injection response.

Due to some problems arising from the breast or the baby, the baby may have problems in grasping and holding the breast. In such cases, a breastfeeding support system can be used.

The breastfeeding support system is based on the logic of stimulating the formation of prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end and the other end inside the bottle/container containing breast milk or formula.With this method, it is aimed to increase milk production and restart breastfeeding through active sucking of the newborn and stimulation of the breasts.

Eligibility Criteria:
1. Inclusion Criteria: Before age of 28 days
2. Exclusion Criteria: After age of 29 days
Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer

Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state.

Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.

Detailed Description:

The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.


Eligibility Criteria:
Inclusion Criteria:

* First-line chemotherapy indicated and accepted by the patient for pancreatic cancer or gastric cancer
* Confirmed diagnosis of pancreatic cancer or gastric cancer
* Free subject, without guardianship or trusteeship or subordination
* Patient benefiting from a social security scheme or benefiting through a third party
* Consent given by the patient after clear and fair information about the study

Exclusion Criteria:

* Age \< 18yo
* Life expectancy ≤10days
* Deep vein thrombosis ou pulmonary embolism ≤3months
* Patient unable to receive chemotherapy (sepsis, acute coronary syndrome, recent stroke, heparin-induced thrombocytopenia, disseminated intravascular coagulation)
* Person enjoying enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situations
* Pregnant or lactating woman and woman of childbearing age lacking effective contraception
Determining the Frequency of Occurrence and Defining the Most Appropriate Screening Test for Anal Intraepithelial Neoplasia (AIN) in Patients With Human Papillomavirus (HPV) Related Gynecological Diseases.

The primary aim of the study is to determine the total risk of AIN in group of HPV-RGD survivors and additionally to establish an exact risk for each of HPV-related gynecological precancers/cancers. Moreover, the most appropriate screening test for HSIL(AIN) in this group of patients will be determined. It will be effectuated by performing two kinds of tests: hrHPV test for the 14 most common oncogenic HPV types and the liquid cytology from both the lower genital tract and anal canal with subsequent high resolution anoscopy (HRA) with potential biopsy/excision of suspected lesions and histopathological examination.


Eligibility Criteria:
Inclusion Criteria:

* HPV related gynecological disease confirmed in histo-pathological examination
* the posibility to obtain material from gynecological organ and from anal canal