cyrilzakka/clinical-trials huggingface dataset:
An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors

The main goal of this project is to identify and remediate the cognitive difficulties, including processing speed and attention deficits in individuals who have undergone chemotherapy treatment. Recent research has demonstrated objective cognitive deficits following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it was once considered. There are a large number of woman diagnosed and treated for breast cancer that experience chemotherapy induced cognitive deficits.

Subjects who participate in the study will be evaluated for cognitive abilities prior to chemotherapy treatment and after completion of chemotherapy. Participants will then have the option to participate in the second phase of the study, which involves the use of a computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive evaluation.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of breast cancer with adjuvant chemotherapy treatment
2. all subjects will be between the ages of 18 and 70 years old
3. free from significant psychiatric history
4. free of current alcohol or drug abuse.
5. All participants need to understand and read English and have the capacity to consent.

Exclusion Criteria:

1. Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer.
2. Individuals younger than 18 years old and older than 70 years old will also be excluded due to developmental changes that occur in those years.
3. Individuals with a current substance use disorder will also be excluded.
4. Individuals who lack the capacity to consent will be excluded from this study.
Observational Pharmaco-Epidemiology Research & Analysis

Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management; and 2) the use of the point-of-care observational data from the provider-patient encounter that support realworld medical research and healthcare quality measure assessment. Real-world evaluations of treatments of chronic diseases in the context of comorbid conditions and special populations (minorities, women, mentally ill, and those with addiction) are limited. The purpose of the OPERA database is to help address this unmet need in clinical research.

Objectives of OPERA

1. To research numerous chronic diseases (HIV, HCV, HBV currently and IBD and RA in the near future, with others as identified for further consideration) utilizing the OPERA® longitudinal database that consists of de-identified EHR data from numerous clinical practices in a variety of settings (e.g. solo practitioners, small groups, and hospitals). Research will be ongoing and yield numerous individual analyses and reports that are authored by epidemiologists, practicing physicians, pharmaco-economists, and other researchers and will target scientific conferences and peer-reviewed medical journals for dissemination.
2. To use epidemiological, statistical, and data analysis methods and related research findings to deliver a sophisticated healthcare analytics reporting solution (CHORUS™) to clinicians.†
3. To enhance patient population management as well as disease management capabilities of the practicing physician.
4. To provide anonymous, nation-wide benchmarking of quality measures and key performance indicators (KPI) for medical clinics.
5. To enhance patient engagement with their physicians to deliver better health outcomes.
6. To evaluate whether engagement in care by patients with their physicians results in better outcomes for patients with chronic illness.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are treated in the practices who enroll and participate in the study
* Patients whose treatment is documented in the practice's electronic health record system

Exclusion Criteria:

* Patients who opt out of OPERA
Effect of Flozin (dapagliflozin) Administration on Myocardial and Peripheral Vascular Remodeling

The aim of this study is to assess the effect of treatment with flozin (dapagliflozin 10mg once a day) on haemodynamic parameters and myocardial and peripheral vascular remodeling in patients with NYHA class II-III heart failure.

In the available literature, there are reports of beneficial effects of flozins on improving myocardial systolic and diastolic function and isolated reports of effects on regression of organ damage (heart, vessels). These drugs significantly improve the prognosis of patients with heart failure, reduce total and cardiovascular mortality, reduce the number of exacerbations and the need for hospitalization, and have a beneficial effect on improving quality of life regardless of coexisting diabetes. New properties demonstrating the pleiotropic effect of the flozins are constantly being discovered. Drugs in this group are highly potent, selective and reversible inhibitors of the sodium ion-dependent glucose cotransporter 2 (SGLT2). The flozins have a low risk of side effects.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed heart failure NYHA class II and III
* consent to participate in the study
* patients should already be receiving treatment with an ACE inhibitor or sacubitril/valsartan or sartans, a beta-blocker, and an MRA, and should start on SGLT2i as part of therapy enhancement

Exclusion Criteria:

-
In Vivo Efficacy Study of Patient Preoperative Preps

The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70% On the abdominal site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any race
* Subjects in good health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Effects Whole Body Vibration in Ergospirometrics Parameters and Quality of Life

This study makes sure that the training of whole body vibration induces changes in ergospirometric parameters, in strength and influence in quality of life in healthy elderly. A case that is run like a vibration training combined, increasing strength and VO2.

The search use the spirometric values after whole body vibration training and resistance training

Eligibility Criteria:
Inclusion Criteria:

* aged 60 to 74 years
* sedentary or irregularly active according to the IPAQ short form with no known diseases

Exclusion Criteria:

* smoking
* acute hernia
* thrombosis
* labyrinthitis
* diabetes
* hemodynamic instability
* obesity
* osteoporosis
* neuromuscular diseases
* pulmonary comorbidities
* heart disease
* electrocardiographic changes during exercise
* taking medications that affected bone metabolism or muscle and don't adapt to any of the protocols
A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years

The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.

HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increased risk for cervical cancer compared to uninfected women. The quadrivalent HPV vaccine marketed as "Gardasil" has demonstrated efficacy against type specific HPV infections known to cause 70% cervical cancer (HPV 16 \& 18) and HPV 6 \& 11 known to cause 90% of anogenital warts in populations of HIV negative young women.

Since the risk of HPV exposure persists throughout a person's sexual life, the duration of protection, especially when the vaccine is given in the pre-adolescent period, is critical to overall vaccine effectiveness. Extended follow up of HIV-uninfected individuals has shown sustained response to HPV vaccine for 8.4 and 6 years respectively to the bivalent and quadrivalent vaccines. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.

Data on immunogenicity of the HPV vaccine among HIV infected adolescents is limited to a 12 month follow up period.

Current HPV vaccine guidelines target pre-sexual adolescents. Since the risk of HPV exposure persists throughout an individual's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. Duration of sustained HPV 6/11/16/18 antibody response is directly related to vaccine effectiveness and determines the need for booster dosing.

The investigators therefore propose to extend follow up of 179 girls and boys in Kenya, age 9-14 years who have received 3 doses of the quadrivalent 'Gardasil' vaccine and assess for immunogenicity annually.

Study Location: Partners in Prevention, Thika site

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* age 9-14 years
* guardian/parental consent

Exclusion Criteria:

Participants will be excluded if they

* are severely ill as defined by Karnofsky \<70
* have a diagnosis of malignancy
* on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
* have received systemic corticosteroids within prior one year
* have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks
* have history of allergy to any products included in the HPV vaccine
* have received any of blood derivatives within prior 6 months
* are pregnant
* lack parental consent and/or parent declines to provide assent
Inspiratory Muscle Training in People With Long COVID-19- A Pilot Investigation.

This pilot investigation will recruit people with Long COVID to participate in a 4 week individualized inspiratory muscle training intervention with pre and post spirometry testing and additional functional outcomes to assess the effectiveness of the intervention.

The study design is a 4 - week parallel-arm intervention, randomised controlled trial. Participants will attend 2 testing days, baseline and follow-up 4 weeks apart.

Participants will first be screened over the phone to assess eligibility. Participants will then be randomly allocated using minimisation, into either control or intervention arm.

Baseline testing:

Participants will undergo baseline testing in the laboratory.

Participants will be measured for their anthropometrics; height and weight. Participants will complete a series of questionnaires for 15 mins.

Following 15 minutes rest, participants will then have three resting blood pressure and heart rate measurements and averaged via a sphygmomanometer and polar HR watch.

MIP will be measured using the MicroRPM care fusion 3 times and the highest value reported (10 minutes). Forced expiratory value in 1 second (FEV1) and peak expiratory flow (PEF) will be measured using Vitalograph 700 (Spirotrac 6).

Participants will undergo a 6-minute-walk-test self-paced where Rating of perceived exertion (RPE) and Borg dyspnea scale (BDS) will be assessed each minute. Then a sub-maximal exercise test using a cycle ergometer and VyntusCPX, where Ventilatory threshold (VT) and Maximal heart rate (HRMax)will be measured. Participants will be asked to cycle until they reach a 17 RPE on a ramp test of 10-15W/min (\>20mins). Heart rate (HR), Rating percieved exertion (RPE) and Borg dyspnea scale BDS) measured each minute.

The intervention arm will receive a handheld PrO2 device and will participate in two unsupervised sessions and one supervised via Microsoft teams sessions per week. Participants will complete 3 sessions per week, for 4 weeks. Each session will include 6 x 6 inspirations at 80% of MIP. MIP will be measured on the supervised session day. The control group will be asked to continue as normal throughout the 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Experiencing self reported Dyspnea (Breathlessness) following COVID-19 infection over 3 months ago.
* Aged between 18 and 65

Exclusion Criteria:

* Are pregnant
* Receiving treatment following a previous cardiac event (Myocardial-infarction and Non-ST elevation MI),
* Have a dementia diagnosis,
* Have a high risk of falls,
* Have an additional chronic respiratory disease diagnosis such as (Chronic obstructive pulmonary disease) COPD or CF (cystic fibrosis)
* Are receiving respiratory muscle training
* Are receiving steroid inhaler treatment
Mechanistic Study on the Diagnosis of Esophageal Cancer Lymph Node Metastasis Using Spectral CT, Multimodal MRI, FAPI PET-CT, Pathology, and AI Evaluation System

The objective of this study is to address the urgent issues in the diagnosis of lymph node metastasis in esophageal cancer. By employing multimodal MRI, spectral CT imaging and FAPI PET-CTtechniques, the study will correlate lymph node images with postoperative pathology results. Additionally, AI technology will be applied to learn from multimodal imaging data, enabling comprehensive analysis and evaluation of lymph node metastasis. Using a large volume of clinical and imaging data, a predictive model will be established to provide individualized lymph node metastasis risk assessments for each esophageal cancer patient. This will, in turn, offer robust support for personalized treatment strategies in esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with pathological diagnosis of esophageal cancer.
2. Patients underwent radical esophagectomy and lymph node dissection, with preoperative multimodal MRI, spectral CT and FAPI PET-CT ; patients underwent neoadjuvant therapy followed by radical surgery, with preoperative multimodal MRI, spectral CT and FAPI PET-CTboth before and after neoadjuvant therapy.
3. No history of malignant tumors or cancer-related treatments.
4. Complete postoperative pathological data, allowing for a one-to-one comparison of preoperative lymph node imaging and postoperative histopathology for evaluation.

Exclusion Criteria:

1. Contraindications for MRI, spectral CT or FAPI PET-CT.
2. Patients who refuse to participate in this study.
Workplace-Sponsored Diet and Exercise Program to Reduce Obesity

This study will evaluate the effectiveness of an environmental worksite intervention to reduce obesity among hospital employees.

BACKGROUND:

Obesity is a significant public health problem in the United States, prompting policy makers and researchers to call for action against the epidemic. Obesity and associated health conditions affect all age groups and both genders, yet disproportionately affect racial and ethnic minorities. Health consequences of obesity include high blood pressure, high cholesterol, hyperinsulinemia, type 2 diabetes, heart disease, stroke, gallbladder disease, arthritis, sleep disturbances, breathing problems, and certain types of cancer. Hospitals are important worksite environments that employ large numbers of people in diverse job categories from diverse educational and socioeconomic backgrounds.

DESIGN NARRATIVE:

The purpose of this study is to promote weight loss among those who are overweight and obese, and prevent weight gain among those of normal weight through an environmental intervention targeted to all employees at six hospitals in central Massachusetts. The hospitals will be matched according to size, and within each matched pair randomly assigned to either the intervention or control group. The intervention will promote active living, in which physical activity is incorporated into each participants' daily routine. Participants will also follow a healthy diet, characterized by higher intakes of fruits, vegetables, fish, poultry, legumes, and whole grains. Participants will consume less high fat foods and refined grains, and reduce their total caloric intake through smaller portion sizes.

Eligibility Criteria:
Inclusion criteria:

* Works at least 20 hours per week at a participating hospital
* Speaks English or Spanish

Exclusion criteria:

* Works at only one hospital within the participating hospital system
CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient

The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

The hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. In particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of QOL (secondary objective). It is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Patient died in the institution
* Patient for which the reliable person has been identified
* Acceptation of the reference physician to send a letter of condolence with the proposed consultation

Exclusion Criteria:

* The physician already met with the caregiver after the patient's death
CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with cyclophosphamide and rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works in treating patients with chronic lymphocytic leukemia.

OBJECTIVES:

Primary

* Evaluate the efficacy, in terms of complete remission rate, of fludarabine phosphate, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia.

Secondary

* Determine the time to treatment failure (TTF) in these patients.
* Determine the overall survival of these patients until 10th January 2019.
* Assess the predictive value of immunophenotype, hypermutation analysis, and FISH in determining TTF and OS in these patients.
* Determine the safety profile of this regimen.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV over 30 minutes or orally and cyclophosphamide IV or orally on days 1-3 and pegfilgrastim subcutaneously on day 4. Starting on course 2, patients receive rituximab IV on day 1. Treatment repeats every 28 days for up to 6\* courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients achieving negative minimal residual disease receive 4 courses of treatment.

Blood samples are collected periodically for biomarker analysis. Samples are analyzed for protein expression (i.e., CD38, CD20, and ZAP70) by flow cytometry; quantitative immunoglobulins, β2-microglobulin, and T-cell subsets by electrophoresis; IgVH mutation status; and cytogenetics (i.e., +12, del 13q, del 11q, and del 17p) by FISH.

After completion of study therapy, patients are followed every 6 months for 5 years and then annually until 10th January 2019.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia

  * Stage I-IV disease (Binet stage progressive A, B, C)
  * CD5 and CD23 positive
  * Untreated OR relapsed/resistant disease after combination chemotherapy or rituximab
  * No 17p deletion

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 1 year
* Creatinine clearance ≥ 50 mL/min
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent malignancy except for noninvasive cervical cancer or localized nonmelanomatous skin cancer
* No history of anaphylaxis to mouse-derived humanized monoclonal antibody
* No other severe concurrent (e.g., cardiac or pulmonary) diseases or mental disorders that could interfere with ability to participate in the study

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)

The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered "superior" in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care.

After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.

Eligibility Criteria:
Inclusion Criteria:

* Obstetric service patients (receiving prenatal care from the Faculty Medical Center)
* Women greater than 18 years old
* Singleton gestation
* Cesarean Section performed by Pfannenstiel skin incision

Exclusion Criteria:

* History of drug or alcohol abuse
* Contraindication to post operative NSAID's or Narcotics
* Emergent Cesarean Deliveries
* Less then 18 years of age