cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of the Haymakers for Hope Fitness Program

This research study is assessing the effect of an exercise program on cancer survivors.

The exercise program is Haymakers for Hope 16-week exercise program

This is a pilot study, it is the first time investigators are examining the effect of this exercise program on cancer survivors physical and emotional functioning. The exercise programs is based on the conditioning program used by boxers.- Haymakers for Hope 16-week exercise program

* The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Participants will attend the 16-week program of boxing conditioning. It is expected that about 10 people will take part in this research study.

  * This 16 week will include supervised exercises designed to improve strength, flexibility, balance and cardiopulmonary fitness.
  * There will be 4 sessions of 1 hour each week for each of the 10 participants.
  * The program will be conducted at gymnasiums contracted with the H4H program and outcomes assessments at Massachusetts General Hospital and the gymnasiums..

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis excluding non-melanoma skin cancer
* Age ≥ 18 years
* ECOG performance status ≤1
* Medical clearance by treating clinician
* No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade 3, or myocardial infarction within 1- year.
* Able to complete forms and understand instruction in English
* Willing and able to attend the H4H program for 16 weeks
* Willing and able to complete the baseline and follow-up visits at MGH
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Participants who have had surgery within 4 weeks prior to entering the study or those who have not recovered from adverse events due to surgery more than 4 weeks earlier.
* Blastic or lytic bone lesions
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Chest pain brought on by physical activity
* Pregnant women or women intending to become pregnant during the study period
* Presence of dementia or major psychiatric illness that would preclude participation in a group program
Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children

To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.

This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children between
* 2 to 9 years old.
* No history of antibiotic use prior 1 month of enrollment
* No history of invasive pneumococcal disease
Gut Microbiota in Chronic GI Diseases

The study involves characterizing the microbiota of patients with IBS, functional diarrhea, IBD, severe motility disorders and celiac disease.

This will be complemented by a translational phase of human-mouse hybrid experiments in which germ-free mice will be colonized with feces from these patients with different GI disease and non-disease controls and we will compare symptoms, microbiota composition and histological changes in the gut and in the brain of the mice.

A complex community of microbes collectively referred to as microbiota, inhabit the human body. The intestinal microbiota is a diverse and dynamic ecosystem, which has developed a mutualistic relationship with its host and plays a crucial role in the development of the host's innate and adaptive immune responses. This ecosystem serves the host by protecting against pathogens, harvesting otherwise inaccessible nutrients, aiding in neutralization of drugs and carcinogens, and affecting the metabolism of lipids. Gut bacteria modulate intestinal motility, barrier function and visceral perception. A better understanding of the role of microbiota in the proposed GI diseases will have profound impact in the characterization of future biomarkers and has also potential treatment implications. As the microbiota may be disturbed in the mentioned GI conditions, a possible treatment approach could be to correct dysbiosis either by the administration of an antibiotic or a preparation of 'beneficial' bacteria (probiotics) according to each bacteria profile.

General Objective The objective of this study is to identify different patterns of intestinal microbiota in patients diagnosed with inflammatory bowel disease, microscopic colitis, functional diarrhea, severe motility disorders, celiac disease and irritable bowel syndrome and to compare it with non-disease controls, by assessing data (questionnaires) and samples (stool, blood and tissue) from single time point (endoscopy/colonoscopy appointment).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IBD, active celiac disease (aTTG positive + endoscopic view and histological findings compatible), IBS (Rome IV criteria or physician diagnosis) severe motility disorders (severe constipation, severe functional dyspepsia) gluten sensitivity (IBS diarrhea predominant with positive anti gliadin antibodies and negative aTTG), functional diarrhea (Rome IV criteria), anal fissure and/or fistula or non-disease control individual or 1st degree family member of celiac patient.
* Willingness to participate
* Signed Informed Consent

Exclusion Criteria:

* Antibiotics in the last month
* Probiotics in the previous month
Impact of Chronic Kidney Disease on Clopidogrel Effects in Diabetes Mellitus

Patients with diabetes mellitus (DM) and chronic kidney disease (CKD) are at increased risk of atherothrombotic events. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease (CAD). However, despite its benefits, many patients still experience recurrent atherothrombotic events. The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism.

Patients with diabetes mellitus (DM) and coexisting chronic kidney disease (CKD) are at increased risk of atherothrombotic events, underscoring the importance of secondary prevention antiplatelet therapy in these high-risk patients. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor in patients with coronary artery disease (CAD). However, despite its clinical benefits, many patients still experience recurrent atherothrombotic events. This is in part due to the impaired effects of clopidogrel in DM patients, particularly among those with coexisting CKD. However, underlying mechanism(s) leading to magnification of impaired clopidogrel response among DM patients with CKD remain unexplored. The ever growing prevalence of CKD in patients with DM and their high risk of recurrent events underscores the need to define such mechanism(s) as this may set the basis for identifying treatment regimens leading to more effective platelet inhibition and cardiovascular protection in these high-risk patients. The proposed study will test the central hypothesis that in DM patients the presence of CKD reduces clopidogrel-mediated P2Y12 inhibitory effects through synergistic mechanisms, which include upregulation of the P2Y12 signaling pathway and impaired clopidogrel metabolism. Comprehensive pharmacokinetic and pharmacodynamic assessments, including ex vivo and in vitro experiments, evaluating the impact of CKD on antiplatelet drug response in DM patients are proposed.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM, defined according to ADA definition, on treatment with oral hypoglycemic agents and/or insulin
* Angiographically documented CAD
* On treatment with low-dose aspirin (81mg/day) for ≥30 days as part of standard of care.

Exclusion Criteria:

* Use of any antiplatelet therapy (except aspirin) in prior 30 days
* Use of parenteral or oral anticoagulation
* Active bleeding
* High risk of bleeding
* Clinical indication to be on a P2Y12 receptor inhibitor
* End-stage renal disease on hemodialysis
* Any active malignancy
* Platelet count \< 100x106/µl
* Hemoglobin \<9 g/dl
* Severe known liver disease
* Hemodynamic instability
* Known allergy to clopidogrel
* Pregnant / lactating females (women of childbearing age must use reliable birth control).
Analysis of Biologic Signatures in Crohn's Patients Undergoing Surgery

The purpose of this study is to compare the effect of two procedures - the Kono-S procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. The investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.

These are two are different ways to re-connect the intestines after a portion of it is removed during surgery. Patients will be randomly assigned to either be re-connected with a procedure called the Kono-S anastomosis or with a side-to-side anastomosis during their surgery. This study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. Then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. This will be used to see how the microbiome and immune system in that area changed since the surgery. Genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Crohn's ileitis/ileocolitis requiring surgical resection OR patients previously enrolled in the "Kono-S anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn's Disease (WC IRB #1303013645)" trial.
2. Patients age 18 years and older.
3. All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3) according to the Vienna classification.
4. Patients will be included regardless of preoperative medications (untreated, steroids, biologics)

Exclusion Criteria:

1. Patients under 18 years of age.
2. Pregnant patients.
3. Patient does not speak English
4. Patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation
EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer

Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic.

This is because the methods and the consequence of following these patients is unknown.

Therefore the investigators will randomize these patients in to two groups:

1. One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department.
2. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.


Eligibility Criteria:
Inclusion Criteria:

* R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.
Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Female breast cancer is the second leading cause of global cancer incidence in 2022 and the fourth leading cause of cancer mortality worldwide. Breast cancer (BC) remains the most prevalent cancer diagnosis among women; nevertheless, considerable advancements in diagnostics and treatment approaches have significantly enhanced patient outcomes. In locally advanced cases, primary systemic chemotherapy is often indicated, and the choice of treatment is influenced by the evaluation of routine prognostic and predictive factors.

Neoadjuvant chemotherapy (NCT) has emerged as a valuable approach to enhance the quality of life ,disease-free and overall survival for early and locally advanced BC patients Approximately 30% of BC cases achieve a pathological complete response (pCR) following NCT. Unfortunately, proper quantification of estrogen- and progesterone receptors (ER and PR), human epidermal growth factor receptor-2 (HER2/Neu) and proliferation markers are insufficient to predict chemosensitivity of some breast tumors , so the identification of these cases during routine pathological examination of biopsy specimens could be especially useful in planning the oncotherapeutic strategy for proper patient management.

CD10, has recently gained attention as an independent diagnostic and prognostic marker in various solid tumors with significant metastatic potential. This molecule has been shown to play a role in cell adhesion, migration, and extracellular matrix remodelling.

A strong CD10 expression has been linked to hormone receptor negativity and HER-2/neu overexpression in breast cancer. Moreover, the dynamics of stromal CD10 expression undergo changes during neoadjuvant anthracycline-based chemotherapy.

Recent research, has presented compelling data indicating that CD10 expression may serve as a predictive marker for the impact of neoadjuvant chemotherapy in breast cancer patients.

Formalin fixed paraffin embedded tissue specimen of the baseline TCNB of locally advanced breast cancer will be obtained from pathology laboratory, Pathology Department, Assiut University.

* Histological diagnosis of H\&E stained sections will be confirmed.
* Immunohistochemical staining for CD10 .
* Baseline clinicopathological features of patients who will receive neoadjuvant chemotherapy will be collected from patients' records.
* Correlation between CD10 expression and the baseline clinicopathological features with the response to neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years
* Pathologically proven breast carcinoma
* Locally advanced breast cancer

Exclusion Criteria:

* Patients below 18 years.
* Patients with metastatic disease
* Patients with second primary cancer
* Patients ineligible for chemotherapy
Inhaled Steroids for the Treatment of Early Pediatric Acute Respiratory Distress Syndrome

The purpose of this study is to show that inhaled steroids in patient with PARDS can decrease the days on mechanical ventilator measured by ventilator-free days,to improve the oxygenation index (OI) or oxygenation saturation index (OSI) in patients receiving inhaled steroids and to show the relevance and feasibility of a larger study by assessing the hypothesis in a small cohort of patients. Patient will be treated for a maximum of 10 days. Secondary objectives are to reduce the length of stay (LOS) in the pediatric intensive care unit (PICU) and hospital admissions; to show less inflammation in the patients receiving inhaled steroids by measuring inflammatory markers from tracheal aspirates like Interleukin (IL6, IL8, tumor necrosis factor (TNF) α, matrix metalloproteinase8 (MMP8) and matrix metalloproteinase9 (MMP9). Lastly, to show that inhaled steroids can improve residual lung disease evaluated by Pulmonary Function Test (PFTs) and Impulse Oscillometry (IOS).


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients older than 30 days and up to 18 years of age admitted to the PICU with a diagnosis of PARDS enrolled within 72 hours of diagnosis.
* Patients requiring invasive mechanical ventilation.
* Criteria of PARDS as defined by the Pediatric Acute Lung Injury Consensus Conference (PALICC), on June 2015 in Pediatric Critical Care Journal

Exclusion Criteria:

* Patients with diffuse alveolar hemorrhage.
* Patients terminally ill with limitation of care or in hospice care.
* Patients receiving inhaled steroids or systemic steroids as chronic therapy before admission.
* Patients with high dose systemic steroids for anti-inflammatory purposes. The investigators will not exclude patients receiving hydrocortisone for shock.
Efficacy of Etoricoxib on Peripheral Hyperalgesia

The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.

Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years with
* Persistent moderate or severe pain (\> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
* Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
* One of the two following QST phenotypes at the baseline assessment:

  * signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
  * without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
* Patients of both gender
* Signed consent form
* Patients with the ability to understand and follow the instructions of the doctor

Exclusion Criteria:

* Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.

Excluded will be also all patients with contradictions for the use of Etoricoxib:

* Hypersensitivity to the active substance or to any of the excipients.
* Active peptic ulceration or active gastrointestinal (GI) bleeding.
* Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
* Pregnancy and lactation
* Severe hepatic dysfunction (serum albumin \<25 g/l or Child-Pugh score ≥10).
* Estimated renal creatinine clearance \<30 ml/min.
* Inflammatory bowel disease.
* Congestive heart failure (NYHA II-IV).
* Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
* Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
* Intake of one of the following drugs (current or in the last 3 days)

  * selective-serotonin-reuptake-inhibitor
  * cetoconazole
  * rifampicin
  * phenytoin
  * carbamazepine
  * dexamethasone or other systemic corticoids
  * traditional nonsteroidal antiphlogistics
  * cyclooxygenase-inhibitors
  * immunosuppressives
  * TNF-α-inhibitors
The Relationship Between Renal Functions and Multi Drug Resistant Organisms

Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in patients receiving invasive mechanical ventilation (MV). Antibiotic resistance poses an increasing threat due to the rise of infections caused by multidrug-resistant organisms (MDROs).Despite the increase in the frequency of MDRO colonisation and infection in dialysis patients, it is not known enough whether the risk of multi-drug resistant (MDR) pneumonia increases in mild-to-severe chronic kidney disease (CKD) (eGFR \<60 mL/min/1.73 m2) patients not receiving dialysis. Therefore, in our study, the investigators aimed to evaluate the relationship between renal functions and MDR VAP risk and the specific microbial pattern.

This prospective observational study was performed on adult patients intubated and receiving MV for at least 48 hours in the 42-bed surgical and medical Intensive Care Unit. The study was conducted between August 2019 and January 2021 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from patients participating in the study or from their relatives. The characteristics of patients with MDRO infection associated with different eGFR categories in VAP patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years of age and above
* A clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines
* A Clinical Pulmonary Infection Score (CPIS) \> 6
* No signs and symptoms of infection at the time of admission to the ICU

Exclusion Criteria:

* Acute kidney injury
* Renal replacement treatment (RRT)
* Dialysis
* Renal transplantation
* Active tuberculosis
* Malnutrition
* Immunosuppression (neutropenia, HIV positivity, transplantation, prednisone treatment of ≥20 mg/day, etc.)
* Any extrapulmonary infection other than VAP at the time of being included in the study
* Respiratory cultures presented fungal agents
* Normal flora
* No growth
Collaborative Connected Health (CCH) for PCORI

The investigators propose to evaluate whether an innovative collaborative connected health (CCH) model increases access to specialists and improves patient outcomes. CCH offers multiple modalities for patients and primary care providers (PCPs) to access dermatologists online directly and asynchronously to maximize effectiveness in a real-world setting. CCH also fosters team care and patient engagement through active sharing of management plans and multidirectional, informed communication among patients, PCPs, and dermatologists. The specific aims of the proposal are to (1) determine whether the CCH model results in equivalent improvements in psoriasis disease severity compared to in-person care, (2) determine whether the CCH model results in equivalent improvements in quality of life and mental health compared to in-person care, and (3) assess whether the CCH model provides better access to care than in-person care.

The investigators propose to conduct a 12-month, pragmatic, randomized controlled trial to evaluate the impact of a collaborative connected health model for psoriasis management compared to inperson care. The pragmatic trial will compare psoriasis severity, quality-of-life, mental health, and access-to-care between the two models. We will enroll 300 psoriasis patients from Colorado and California. In addition to recruiting patients from the general population, we will place a specific emphasis on recruiting psoriasis patients living in rural and underserved communities. We will also recruit from the full disease spectrum of mild, moderate, and severe psoriasis patients. We will use an intention-to-treat approach to analyze outcomes and perform longitudinal data analysis using repeated measures approach to identify potential differences in the trend over time between the two arms. To evaluate the utility of CCH for increasing access from patients' and clinicians' perspective, the study team will conduct key informant interviews and use qualitative analytical techniques with investigator triangulation and member checking to enhance the validity of the conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Be age 18 years and older
* Have physician-diagnosed plaque psoriasis
* Have access to internet and a digital camera or a mobile phone with camera features
* Have a primary care provider or the ability to establish primary care

Exclusion Criteria:

-